{ "name": "Radiance Face Serum", "fictional": true, "scope": "United States \u00b7 nationwide state screening \u00b7 Amazon", "original": "Radiance Face Serum\nTreats eczema and cures acne overnight.\nIngredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol.\nDirections: Apply a small amount to clean skin.\nManufactured by Example Beauty, Austin, TX\n", "corrected": "Radiance Face Serum\nSoothes and improves the look of skin.\n\nNet Contents 1 fl oz (30 mL)\n\nIngredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol.\n\nDirections: Apply a small amount to clean skin.\n\nWarnings:\nKeep out of reach of children.\nAvoid contact with eyes. If contact occurs, rinse thoroughly with water.\nFor external use only.\nDiscontinue use if irritation or rash occurs.\n\nManufactured by Example Beauty, 100 Example St, Austin, TX 78701\n\nQuestions or adverse event reports: safety@example.invalid", "inputs": { "replacedClaims": [ "Soothes and improves the look of skin." ], "removedClaims": [], "keptClaims": [], "removedIngredients": [], "netQtyAmount": "1", "netQtyUnit": "fl oz", "mfrLine": "Manufactured by Example Beauty, 100 Example St, Austin, TX 78701", "aeContact": "safety@example.invalid" }, "asks": { "needsNetQtyUnit": false, "netQtyMissing": true, "mfrMissing": false, "mfrAddrIncomplete": true, "ingredientsMissing": false, "identityMissing": false, "aeContactMissing": true, "hasProp65": false, "hasDrugClaims": true, "wrNeedsInput": false, "hasFlaggedIngredients": false }, "before": { "retailer_programs_violated": 1, "status": "fail", "verdict": "fail", "issue_counts": { "issue_blocking": 7, "issue_caution": 3, "issue_total": 10, "rule_total": 10 }, "verdict_tier": "red", "verdict_markers": [ "advisories" ], "violations": [ { "code": "701.13.net_quantity_present", "title": "Net quantity of contents present", "description": "PDP must include net quantity by weight, measure, or count.", "severity": "error", "regulation": "21 CFR 701.13", "citation_url": null, "evidence": null, "suggested_fix": "Add a net quantity statement on the PDP (choose the form that matches the product and supplied facts; for example, \"Net Wt. 1 oz (28 g)\" for weight or \"Net Contents 1 fl oz (30 mL)\" for liquid volume).", "fix_text": "Net Wt. [AMOUNT] oz ([AMOUNT] g) or Net Contents [AMOUNT] fl oz ([AMOUNT] mL)", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Net quantity of contents present", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Principal display panel: net quantity statement", "what_we_detected": "We did not find a recognizable net quantity statement in the label text.", "why_it_matters": "PDP must include net quantity by weight, measure, or count.", "rule": "701.13.net_quantity_present", "authority": "FDA", "citation": "21 CFR 701.13", "citation_url": null, "recommended_action": "Add a net quantity statement on the PDP (choose the form that matches the product and supplied facts; for example, \"Net Wt. 1 oz (28 g)\" for weight or \"Net Contents 1 fl oz (30 mL)\" for liquid volume).", "compliant_example": "Net Wt. [AMOUNT] oz ([AMOUNT] g) or Net Contents [AMOUNT] fl oz ([AMOUNT] mL)", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1, "display_title": "Net quantity is missing." }, { "code": "MOCRA.adverse_event_contact", "title": "Domestic contact for adverse event reports missing", "description": "MoCRA requires every cosmetic label to bear a domestic address, domestic phone number, or electronic contact such as a website, through which you can receive adverse event reports. Any one of the three satisfies the requirement.", "severity": "error", "regulation": "21 U.S.C. \u00a7 364e(a) (FD&C Act \u00a7 609(a); MoCRA, eff. Dec. 29, 2024)", "citation_url": null, "evidence": null, "suggested_fix": "Add one of: a US mailing address, a US phone number, or a website or email address. If your label already carries a complete US 'Manufactured by' or 'Distributed by' line, that satisfies this requirement, you do not need to add a separate adverse-event contact line.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Domestic contact for adverse event reports missing", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Information panel: adverse event contact", "what_we_detected": "We did not find a recognizable domestic address, phone number or electronic contact for adverse event reports in the label text.", "why_it_matters": "MoCRA requires every cosmetic label to bear a domestic address, domestic phone number, or electronic contact such as a website, through which you can receive adverse event reports. Any one of the three satisfies the requirement.", "rule": "MOCRA.adverse_event_contact", "authority": "FDA", "citation": "21 U.S.C. \u00a7 364e(a) (FD&C Act \u00a7 609(a); MoCRA, eff. Dec. 29, 2024)", "citation_url": null, "recommended_action": "Add one of: a US mailing address, a US phone number, or a website or email address. If your label already carries a complete US 'Manufactured by' or 'Distributed by' line, that satisfies this requirement, you do not need to add a separate adverse-event contact line.", "compliant_example": "Questions or adverse reactions: [1-800-000-0000] or [care@yourbrand.com]", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1, "display_title": "Domestic contact for adverse event reports missing" }, { "code": "701.12.manufacturer_address_zip_missing", "title": "Manufacturer place of business is missing the ZIP code", "description": "21 CFR 701.12(d) requires the place of business to include the street address, city, state, and ZIP code; only the street address may be omitted, and only for a firm listed in a current city or telephone directory. The line \"Manufactured by Example Beauty, Austin, TX\" names a US city and state but no ZIP code.", "severity": "warning", "regulation": "21 CFR 701.12(d)", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12", "evidence": "Manufactured by Example Beauty, Austin, TX", "suggested_fix": "Add the five-digit ZIP code after the state, e.g. \"Los Angeles, CA 90001\". 21 CFR 701.12(d) lets a directory-listed firm omit the street address, but never the ZIP code.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Manufacturer place of business is missing the ZIP code", "status": "warning", "severity": "warning", "priority": 2, "affected_area": "Information panel: name and place of business", "what_we_detected": "We did not find a recognizable ZIP code in the place of business in the label text.", "why_it_matters": "21 CFR 701.12(d) requires the place of business to include the street address, city, state, and ZIP code; only the street address may be omitted, and only for a firm listed in a current city or telephone directory. The line \"Manufactured by Example Beauty, Austin, TX\" names a US city and state but no ZIP code.", "rule": "701.12.manufacturer_address_zip_missing", "authority": "FDA", "citation": "21 CFR 701.12(d)", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12", "recommended_action": "Add the five-digit ZIP code after the state, e.g. \"Los Angeles, CA 90001\". 21 CFR 701.12(d) lets a directory-listed firm omit the street address, but never the ZIP code.", "compliant_example": "Distributed by [Company Name], [City], [State] [ZIP]", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 2, "display_title": "Manufacturer place of business is missing the ZIP code" }, { "code": "warnings.children_best_practice", "title": "Children safety warning (best practice)", "description": "Include 'Keep out of reach of children' for potentially irritating products.", "severity": "warning", "regulation": "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels", "citation_url": null, "evidence": null, "suggested_fix": "Add \"Keep out of reach of children\" if the formula carries any irritation risk.", "fix_text": "Keep out of reach of children.", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Children safety warning (best practice)", "status": "warning", "severity": "warning", "priority": 3, "affected_area": "Warning statements", "what_we_detected": "This check matched the label text.", "why_it_matters": "Include 'Keep out of reach of children' for potentially irritating products.", "rule": "warnings.children_best_practice", "authority": "FDA", "citation": "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels", "citation_url": null, "recommended_action": "Add \"Keep out of reach of children\" if the formula carries any irritation risk.", "compliant_example": "Keep out of reach of children.", "example_is_placeholder": false, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 3, "display_title": "Children safety warning (best practice)" }, { "code": "warnings.eye_contact", "title": "Eye-contact warning (best practice)", "description": "If formula may irritate eyes, include 'Avoid contact with eyes.'", "severity": "warning", "regulation": "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement)", "citation_url": null, "evidence": null, "suggested_fix": "Add \"Avoid contact with eyes\" or equivalent eye safety warning.", "fix_text": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Eye-contact warning (best practice)", "status": "warning", "severity": "warning", "priority": 3, "affected_area": "Warning statements", "what_we_detected": "This check matched the label text.", "why_it_matters": "If formula may irritate eyes, include 'Avoid contact with eyes.'", "rule": "warnings.eye_contact", "authority": "FDA", "citation": "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement)", "citation_url": null, "recommended_action": "Add \"Avoid contact with eyes\" or equivalent eye safety warning.", "compliant_example": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "example_is_placeholder": false, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 3, "display_title": "Eye-contact warning (best practice)" }, { "code": "AMZ.net_quantity", "title": "Net quantity required on listing", "description": "Amazon Beauty requires net quantity (weight, volume, or count) visible on the product label and in listing details, mirroring the federal requirement (21 CFR 701.13). Amazon's own cosmetics help page is behind a Seller Central sign-in, so the federal regulation is cited as the verifiable authority.", "severity": "error", "regulation": "Amazon Beauty requirements", "citation_url": null, "evidence": null, "suggested_fix": "Add the required information to your label and product listing.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": "https://www.ecfr.gov/current/title-21/section-701.13", "retailer_consequence": null, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "authority_kind": "retailer", "authority_label": "Amazon Beauty", "remediation": { "title": "Net quantity required on listing", "status": "fail", "severity": "error", "priority": 3, "affected_area": "Retailer program: Amazon Beauty", "what_we_detected": "We did not find a recognizable net quantity statement in the label text.", "why_it_matters": "Amazon Beauty requires net quantity (weight, volume, or count) visible on the product label and in listing details, mirroring the federal requirement (21 CFR 701.13). Amazon's own cosmetics help page is behind a Seller Central sign-in, so the federal regulation is cited as the verifiable authority.", "rule": "AMZ.net_quantity", "authority": "Amazon Beauty", "citation": "Amazon Beauty requirements", "citation_url": "https://www.ecfr.gov/current/title-21/section-701.13", "recommended_action": "Add the required information to your label and product listing.", "compliant_example": null, "example_is_placeholder": false, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "manual_verification": { "required": true, "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission." } }, "priority": 3, "display_title": "Net quantity required on listing" }, { "code": "AMZ.no_drug_claims", "title": "No drug or therapeutic claims permitted", "description": "Amazon prohibits drug claims on cosmetic listings. Words like 'treats', 'cures', 'heals acne', 'anti-inflammatory', 'antibacterial' may require OTC drug registration. This is Amazon's own listing policy, not a legal finding; the federal drug-claim analysis is reported separately. Amazon's cosmetics policy page requires a Seller Central sign-in, so it cannot be opened without a seller account.", "severity": "error", "regulation": "Amazon Beauty requirements", "citation_url": null, "evidence": null, "suggested_fix": "Rephrase or remove this claim to avoid drug/therapeutic language.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "authority_kind": "retailer", "authority_label": "Amazon Beauty", "remediation": { "title": "No drug or therapeutic claims permitted", "status": "fail", "severity": "error", "priority": 3, "affected_area": "Retailer program: Amazon Beauty", "what_we_detected": "This check matched the label text.", "why_it_matters": "Amazon prohibits drug claims on cosmetic listings. Words like 'treats', 'cures', 'heals acne', 'anti-inflammatory', 'antibacterial' may require OTC drug registration. This is Amazon's own listing policy, not a legal finding; the federal drug-claim analysis is reported separately. Amazon's cosmetics policy page requires a Seller Central sign-in, so it cannot be opened without a seller account.", "rule": "AMZ.no_drug_claims", "authority": "Amazon Beauty", "citation": "Amazon Beauty requirements", "citation_url": null, "recommended_action": "Rephrase or remove this claim to avoid drug/therapeutic language.", "compliant_example": null, "example_is_placeholder": false, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "manual_verification": { "required": true, "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission." } }, "priority": 3, "display_title": "No drug or therapeutic claims permitted" } ], "checked_regulations": [ "21 CFR 740.1, Discontinue use if irritation warning", "FD&C Act 505(a) / 21 U.S.C. 355(a) and 503(b)(1)(A) / 21 U.S.C. 353(b)(1)(A); applied in FDA Warning Letter to Lifetech Resources LLC, April 18 2011, Prostaglandin analog in a lash or brow product: unapproved prescription drug", "21 U.S.C. \u00a7 364e(a) / MoCRA, domestic contact for adverse event reports", "21 CFR 701.2, Required information appears in English", "Microbead-Free Waters Act of 2015, 21 U.S.C. 331(ddd), Plastic microbeads prohibited in rinse-off cosmetics", "FD&C Act \u00a7 505(a) / CARES Act \u00a7 505G(a)(4), Not-GRASE active ingredient check", "21 CFR Parts 73 and 74, Color additive approval", "21 CFR 700.13, FDA restricted ingredient: Mercury compounds", "21 CFR 701.3, Ingredient declaration present", "21 CFR 740.1, External use only warning", "FD&C Act \u00a7 601 / 21 U.S.C. \u00a7 361, Coal-tar hair dye caution", "21 CFR 700.23, FDA prohibited ingredient: Chlorofluorocarbon propellants", "40 CFR 82.106, HCFC ozone-depletion warning", "Marine Mammal Protection Act, 16 U.S.C. 1361 et seq.; Endangered Species Act, 16 U.S.C. 1538(a)(1)(E)-(F); Whaling Convention Act, 16 U.S.C. 916c(a)(2); Cal. Penal Code 653o(a), Cetacean-derived ingredient: prohibited from US commerce", "21 CFR 701.12, Complete place of business required", "21 CFR 310.545(a)(1) and (d)(1); 21 CFR 333.310(d) (acne monograph strength), Salicylic acid above 2% in an acne product: unapproved new drug", "21 CFR 700.16, FDA restricted ingredient: Zirconium compounds in aerosol cosmetics", "Panel placement, PDP / information panel structure", "21 CFR 701.11, Identity statement present", "21 CFR 701.13, Net quantity of contents present", "21 CFR 700.15, FDA prohibited ingredient: Halogenated salicylanilides", "21 CFR 700.11, FDA prohibited ingredient: Bithionol", "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement), Eye-contact warning (best practice)", "84 FR 6204 / \u00a7 505G, Category II sunscreen active (not-GRASE, not legally marketable)", "21 CFR 740.1 (cosmetic warning statements; warning required whenever necessary or appropriate to prevent a health hazard), Flammability warning if applicable", "21 CFR 701.3(a), Ingredient declaration format", "21 CFR 700.14, FDA prohibited ingredient: Vinyl chloride", "21 CFR 701.2(b), Foreign-language label consistency", "21 CFR 701.12, Manufacturer or distributor present", "21 CFR 700.18, FDA prohibited ingredient: Chloroform", "84 FR 6204 / \u00a7 505G(b), Category III sunscreen active (GRASE determination pending)", "FD&C Act 505G / 21 U.S.C. 355h; OTC Monograph M017 (External Analgesic Drug Products for OTC Human Use); 21 CFR 201.66, Anesthetic active declared without a Drug Facts panel", "21 CFR 740.17, Foaming detergent bath caution", "21 CFR 740.1 (general cosmetic warning authority); 21 CFR 740.11 for self-pressurized containers, Eye-contact warning", "21 CFR 700.19, FDA prohibited ingredient: Methylene chloride", "21 CFR 700.25, Tamper-resistant packaging statement", "21 CFR 740.12, Feminine deodorant spray caution", "FD&C Act 601(e) / 21 U.S.C. 361(e); 21 CFR Parts 73, 74 and 82 (colour additive listings), FDA prohibited: kohl, kajal, al-kahal or surma", "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels, Children safety warning (best practice)", "21 CFR 250.250, FDA restricted ingredient: Hexachlorophene" ], "violated_regulations": [ "21 U.S.C. \u00a7 364e(a) / MoCRA, domestic contact for adverse event reports", "21 CFR 701.13, Net quantity of contents present", "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement), Eye-contact warning (best practice)", "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels, Children safety warning (best practice)", "21 CFR 701.12, Complete place of business required, ZIP code missing" ], "pass_reasons": [ "Identity statement present: The PDP must clearly identify the product (e.g. 'Face Serum', 'Moisturizing Lotion'). (Evidence: \"Serum\")", "Manufacturer or distributor present: Label must include name and place of business of manufacturer, packer, or distributor. (Evidence: \"Manufactured by Example Beauty, Austin, TX\")", "Required information appears in English: All required label information must appear in English per 21 CFR \u00a7 701.2. If a foreign language also appears anywhere on the label, all required statements must also appear in that foreign language. (Evidence: \"Ingredients\")", "Flammability warning if applicable: No flammable ingredients detected", "Ingredient declaration present: standard ingredient heading detected.", "Ingredient list appears comma-separated", "Prostaglandin analog in a lash or brow product: unapproved prescription drug: not detected in the ingredient declaration", "Salicylic acid above 2% in an acne product: unapproved new drug: not detected in the ingredient declaration", "Anesthetic active declared without a Drug Facts panel: not detected in the ingredient declaration -- benzocaine and lidocaine are the two anesthetic actives this check covers. FDA's monograph M017 lists others (pramoxine, dibucaine, tetracaine, dyclonine, phenol) that this check does not look for -- confirm those by hand.", "FDA prohibited: kohl, kajal, al-kahal or surma: not detected in the ingredient declaration", "Cetacean-derived ingredient: prohibited from US commerce: not detected in the ingredient declaration", "Plastic microbeads prohibited in rinse-off cosmetics: plastic microbeads and plastic polymers not detected in the ingredient declaration", "FDA prohibited ingredient: Bithionol: not detected in the ingredient declaration", "FDA prohibited ingredient: Chloroform: not detected in the ingredient declaration", "FDA prohibited ingredient: Halogenated salicylanilides: not detected in the ingredient declaration", "FDA prohibited ingredient: Methylene chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Vinyl chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Chlorofluorocarbon propellants: not detected in the ingredient declaration", "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics: not detected in the ingredient declaration", "FDA restricted ingredient: Hexachlorophene: not detected in the ingredient declaration", "FDA restricted ingredient: Mercury compounds: not detected in the ingredient declaration", "No not-GRASE active (hydroquinone) detected on label", "No 'Active Ingredient:' header, FD&C \u00a7 505(a) and Category III checks not applicable", "California Prop 65 warning may be required: No prohibited content detected.", "Prop 65 warning does not match the safe-harbor format: No prohibited content detected.", "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762): No prohibited content detected.", "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643): No prohibited content detected.", "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion: No prohibited content detected.", "Banned for sale in California (2027): styrene / vinyl acetate monomer: No prohibited content detected.", "Musk ketone capped in California (2027): concentration limits by product type: No prohibited content detected.", "Banned for sale in California (2027): boron compounds (boric acid / borates): No prohibited content detected.", "Banned for sale in California (2027): Laurus nobilis seed oil: No prohibited content detected.", "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products: No prohibited content detected.", "Louisiana mercury limit in cosmetics (10 ppm): No prohibited content detected.", "New York mercury prohibition in cosmetics: No prohibited content detected.", "New York hair-relaxer carcinogen warning (takes effect May 21, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Minnesota mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Minnesota formaldehyde ban in children's products (under age 8): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Washington Toxic-Free Cosmetics Act: No prohibited content detected.", "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027): No prohibited content detected.", "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Maryland PFAS prohibition in cosmetics (HB 643): No prohibited content detected.", "Banned for sale in Vermont: Act 131 named substances: No prohibited content detected.", "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene: No prohibited content detected.", "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited: No prohibited content detected.", "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027): No prohibited content detected.", "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028): No prohibited content detected.", "Illinois mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Arkansas hair-relaxer carcinogen warning (in force since 2025): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122): No prohibited content detected.", "Virginia PFAS prohibition in cosmetics (HB 122): No prohibited content detected.", "Color additives: no FD&C/D&C colour name was declared on this label" ], "violations_by_category": { "manufacturer": [ { "code": "MOCRA.adverse_event_contact", "title": "Domestic contact for adverse event reports missing", "description": "MoCRA requires every cosmetic label to bear a domestic address, domestic phone number, or electronic contact such as a website, through which you can receive adverse event reports. Any one of the three satisfies the requirement.", "severity": "error", "regulation": "21 U.S.C. \u00a7 364e(a) (FD&C Act \u00a7 609(a); MoCRA, eff. Dec. 29, 2024)", "citation_url": null, "evidence": null, "suggested_fix": "Add one of: a US mailing address, a US phone number, or a website or email address. If your label already carries a complete US 'Manufactured by' or 'Distributed by' line, that satisfies this requirement, you do not need to add a separate adverse-event contact line.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Domestic contact for adverse event reports missing", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Information panel: adverse event contact", "what_we_detected": "We did not find a recognizable domestic address, phone number or electronic contact for adverse event reports in the label text.", "why_it_matters": "MoCRA requires every cosmetic label to bear a domestic address, domestic phone number, or electronic contact such as a website, through which you can receive adverse event reports. Any one of the three satisfies the requirement.", "rule": "MOCRA.adverse_event_contact", "authority": "FDA", "citation": "21 U.S.C. \u00a7 364e(a) (FD&C Act \u00a7 609(a); MoCRA, eff. Dec. 29, 2024)", "citation_url": null, "recommended_action": "Add one of: a US mailing address, a US phone number, or a website or email address. If your label already carries a complete US 'Manufactured by' or 'Distributed by' line, that satisfies this requirement, you do not need to add a separate adverse-event contact line.", "compliant_example": "Questions or adverse reactions: [1-800-000-0000] or [care@yourbrand.com]", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1 } ], "pdp": [ { "code": "701.13.net_quantity_present", "title": "Net quantity of contents present", "description": "PDP must include net quantity by weight, measure, or count.", "severity": "error", "regulation": "21 CFR 701.13", "citation_url": null, "evidence": null, "suggested_fix": "Add a net quantity statement on the PDP (choose the form that matches the product and supplied facts; for example, \"Net Wt. 1 oz (28 g)\" for weight or \"Net Contents 1 fl oz (30 mL)\" for liquid volume).", "fix_text": "Net Wt. [AMOUNT] oz ([AMOUNT] g) or Net Contents [AMOUNT] fl oz ([AMOUNT] mL)", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Net quantity of contents present", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Principal display panel: net quantity statement", "what_we_detected": "We did not find a recognizable net quantity statement in the label text.", "why_it_matters": "PDP must include net quantity by weight, measure, or count.", "rule": "701.13.net_quantity_present", "authority": "FDA", "citation": "21 CFR 701.13", "citation_url": null, "recommended_action": "Add a net quantity statement on the PDP (choose the form that matches the product and supplied facts; for example, \"Net Wt. 1 oz (28 g)\" for weight or \"Net Contents 1 fl oz (30 mL)\" for liquid volume).", "compliant_example": "Net Wt. [AMOUNT] oz ([AMOUNT] g) or Net Contents [AMOUNT] fl oz ([AMOUNT] mL)", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1 } ], "warnings": [ { "code": "warnings.eye_contact", "title": "Eye-contact warning (best practice)", "description": "If formula may irritate eyes, include 'Avoid contact with eyes.'", "severity": "warning", "regulation": "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement)", "citation_url": null, "evidence": null, "suggested_fix": "Add \"Avoid contact with eyes\" or equivalent eye safety warning.", "fix_text": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Eye-contact warning (best practice)", "status": "warning", "severity": "warning", "priority": 3, "affected_area": "Warning statements", "what_we_detected": "This check matched the label text.", "why_it_matters": "If formula may irritate eyes, include 'Avoid contact with eyes.'", "rule": "warnings.eye_contact", "authority": "FDA", "citation": "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement)", "citation_url": null, "recommended_action": "Add \"Avoid contact with eyes\" or equivalent eye safety warning.", "compliant_example": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water.", "example_is_placeholder": false, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 3 }, { "code": "warnings.children_best_practice", "title": "Children safety warning (best practice)", "description": "Include 'Keep out of reach of children' for potentially irritating products.", "severity": "warning", "regulation": "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels", "citation_url": null, "evidence": null, "suggested_fix": "Add \"Keep out of reach of children\" if the formula carries any irritation risk.", "fix_text": "Keep out of reach of children.", "fix_is_label_edit": true, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Children safety warning (best practice)", "status": "warning", "severity": "warning", "priority": 3, "affected_area": "Warning statements", "what_we_detected": "This check matched the label text.", "why_it_matters": "Include 'Keep out of reach of children' for potentially irritating products.", "rule": "warnings.children_best_practice", "authority": "FDA", "citation": "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels", "citation_url": null, "recommended_action": "Add \"Keep out of reach of children\" if the formula carries any irritation risk.", "compliant_example": "Keep out of reach of children.", "example_is_placeholder": false, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 3 } ], "federal": [ { "code": "701.12.manufacturer_address_zip_missing", "title": "Manufacturer place of business is missing the ZIP code", "description": "21 CFR 701.12(d) requires the place of business to include the street address, city, state, and ZIP code; only the street address may be omitted, and only for a firm listed in a current city or telephone directory. The line \"Manufactured by Example Beauty, Austin, TX\" names a US city and state but no ZIP code.", "severity": "warning", "regulation": "21 CFR 701.12(d)", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12", "evidence": "Manufactured by Example Beauty, Austin, TX", "suggested_fix": "Add the five-digit ZIP code after the state, e.g. \"Los Angeles, CA 90001\". 21 CFR 701.12(d) lets a directory-listed firm omit the street address, but never the ZIP code.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "authority_kind": "federal", "authority_label": "FDA", "remediation": { "title": "Manufacturer place of business is missing the ZIP code", "status": "warning", "severity": "warning", "priority": 2, "affected_area": "Information panel: name and place of business", "what_we_detected": "We did not find a recognizable ZIP code in the place of business in the label text.", "why_it_matters": "21 CFR 701.12(d) requires the place of business to include the street address, city, state, and ZIP code; only the street address may be omitted, and only for a firm listed in a current city or telephone directory. The line \"Manufactured by Example Beauty, Austin, TX\" names a US city and state but no ZIP code.", "rule": "701.12.manufacturer_address_zip_missing", "authority": "FDA", "citation": "21 CFR 701.12(d)", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12", "recommended_action": "Add the five-digit ZIP code after the state, e.g. \"Los Angeles, CA 90001\". 21 CFR 701.12(d) lets a directory-listed firm omit the street address, but never the ZIP code.", "compliant_example": "Distributed by [Company Name], [City], [State] [ZIP]", "example_is_placeholder": true, "confidence": "high", "confidence_basis": "Presence-and-format check on a required label element: the text either carries it or it does not.", "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 2 } ], "retailer_amazon": [ { "code": "AMZ.net_quantity", "title": "Net quantity required on listing", "description": "Amazon Beauty requires net quantity (weight, volume, or count) visible on the product label and in listing details, mirroring the federal requirement (21 CFR 701.13). Amazon's own cosmetics help page is behind a Seller Central sign-in, so the federal regulation is cited as the verifiable authority.", "severity": "error", "regulation": "Amazon Beauty requirements", "citation_url": null, "evidence": null, "suggested_fix": "Add the required information to your label and product listing.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": "https://www.ecfr.gov/current/title-21/section-701.13", "retailer_consequence": null, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "authority_kind": "retailer", "authority_label": "Amazon Beauty", "remediation": { "title": "Net quantity required on listing", "status": "fail", "severity": "error", "priority": 3, "affected_area": "Retailer program: Amazon Beauty", "what_we_detected": "We did not find a recognizable net quantity statement in the label text.", "why_it_matters": "Amazon Beauty requires net quantity (weight, volume, or count) visible on the product label and in listing details, mirroring the federal requirement (21 CFR 701.13). Amazon's own cosmetics help page is behind a Seller Central sign-in, so the federal regulation is cited as the verifiable authority.", "rule": "AMZ.net_quantity", "authority": "Amazon Beauty", "citation": "Amazon Beauty requirements", "citation_url": "https://www.ecfr.gov/current/title-21/section-701.13", "recommended_action": "Add the required information to your label and product listing.", "compliant_example": null, "example_is_placeholder": false, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "manual_verification": { "required": true, "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission." } }, "priority": 3 }, { "code": "AMZ.no_drug_claims", "title": "No drug or therapeutic claims permitted", "description": "Amazon prohibits drug claims on cosmetic listings. Words like 'treats', 'cures', 'heals acne', 'anti-inflammatory', 'antibacterial' may require OTC drug registration. This is Amazon's own listing policy, not a legal finding; the federal drug-claim analysis is reported separately. Amazon's cosmetics policy page requires a Seller Central sign-in, so it cannot be opened without a seller account.", "severity": "error", "regulation": "Amazon Beauty requirements", "citation_url": null, "evidence": null, "suggested_fix": "Rephrase or remove this claim to avoid drug/therapeutic language.", "fix_text": null, "fix_is_label_edit": false, "substitute_guidance": null, "source_url": null, "retailer_consequence": null, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "authority_kind": "retailer", "authority_label": "Amazon Beauty", "remediation": { "title": "No drug or therapeutic claims permitted", "status": "fail", "severity": "error", "priority": 3, "affected_area": "Retailer program: Amazon Beauty", "what_we_detected": "This check matched the label text.", "why_it_matters": "Amazon prohibits drug claims on cosmetic listings. Words like 'treats', 'cures', 'heals acne', 'anti-inflammatory', 'antibacterial' may require OTC drug registration. This is Amazon's own listing policy, not a legal finding; the federal drug-claim analysis is reported separately. Amazon's cosmetics policy page requires a Seller Central sign-in, so it cannot be opened without a seller account.", "rule": "AMZ.no_drug_claims", "authority": "Amazon Beauty", "citation": "Amazon Beauty requirements", "citation_url": null, "recommended_action": "Rephrase or remove this claim to avoid drug/therapeutic language.", "compliant_example": null, "example_is_placeholder": false, "confidence": "medium", "confidence_basis": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "manual_verification": { "required": true, "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission." } }, "priority": 3 } ] }, "pass_by_category": { "pdp": [ "Identity statement present: The PDP must clearly identify the product (e.g. 'Face Serum', 'Moisturizing Lotion'). (Evidence: \"Serum\")", "Manufacturer or distributor present: Label must include name and place of business of manufacturer, packer, or distributor. (Evidence: \"Manufactured by Example Beauty, Austin, TX\")", "Required information appears in English: All required label information must appear in English per 21 CFR \u00a7 701.2. If a foreign language also appears anywhere on the label, all required statements must also appear in that foreign language. (Evidence: \"Ingredients\")" ], "warnings": [ "Flammability warning if applicable: No flammable ingredients detected" ], "federal": [ "Ingredient declaration present: standard ingredient heading detected.", "Ingredient list appears comma-separated", "Prostaglandin analog in a lash or brow product: unapproved prescription drug: not detected in the ingredient declaration", "Salicylic acid above 2% in an acne product: unapproved new drug: not detected in the ingredient declaration", "Anesthetic active declared without a Drug Facts panel: not detected in the ingredient declaration -- benzocaine and lidocaine are the two anesthetic actives this check covers. FDA's monograph M017 lists others (pramoxine, dibucaine, tetracaine, dyclonine, phenol) that this check does not look for -- confirm those by hand.", "FDA prohibited: kohl, kajal, al-kahal or surma: not detected in the ingredient declaration", "Cetacean-derived ingredient: prohibited from US commerce: not detected in the ingredient declaration", "Plastic microbeads prohibited in rinse-off cosmetics: plastic microbeads and plastic polymers not detected in the ingredient declaration", "FDA prohibited ingredient: Bithionol: not detected in the ingredient declaration", "FDA prohibited ingredient: Chloroform: not detected in the ingredient declaration", "FDA prohibited ingredient: Halogenated salicylanilides: not detected in the ingredient declaration", "FDA prohibited ingredient: Methylene chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Vinyl chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Chlorofluorocarbon propellants: not detected in the ingredient declaration", "FD&C \u00a7 505(a), no not-GRASE active detected", "FD&C \u00a7 505(a) / 84 FR 6204, No active ingredient header detected" ], "ingredient_restrictions": [ "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics: not detected in the ingredient declaration", "FDA restricted ingredient: Hexachlorophene: not detected in the ingredient declaration", "FDA restricted ingredient: Mercury compounds: not detected in the ingredient declaration" ], "state_CA": [ "California Prop 65 warning may be required: No prohibited content detected.", "Prop 65 warning does not match the safe-harbor format: No prohibited content detected.", "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762): No prohibited content detected.", "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion: No prohibited content detected.", "Banned for sale in California (2027): styrene / vinyl acetate monomer: No prohibited content detected.", "Musk ketone capped in California (2027): concentration limits by product type: No prohibited content detected.", "Banned for sale in California (2027): boron compounds (boric acid / borates): No prohibited content detected.", "Banned for sale in California (2027): Laurus nobilis seed oil: No prohibited content detected." ], "state_MD": [ "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643): No prohibited content detected.", "Maryland PFAS prohibition in cosmetics (HB 643): No prohibited content detected." ], "state_WI": [ "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products: No prohibited content detected." ], "state_LA": [ "Louisiana mercury limit in cosmetics (10 ppm): No prohibited content detected." ], "state_NY": [ "New York mercury prohibition in cosmetics: No prohibited content detected.", "New York hair-relaxer carcinogen warning (takes effect May 21, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_MN": [ "Minnesota mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Minnesota formaldehyde ban in children's products (under age 8): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_WA": [ "Washington Toxic-Free Cosmetics Act: No prohibited content detected.", "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027): No prohibited content detected.", "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_CO": [ "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_VT": [ "Banned for sale in Vermont: Act 131 named substances: No prohibited content detected.", "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene: No prohibited content detected." ], "state_HI": [ "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited: No prohibited content detected." ], "state_OR": [ "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027): No prohibited content detected." ], "state_IL": [ "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028): No prohibited content detected.", "Illinois mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected." ], "state_AR": [ "Arkansas hair-relaxer carcinogen warning (in force since 2025): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_VA": [ "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122): No prohibited content detected.", "Virginia PFAS prohibition in cosmetics (HB 122): No prohibited content detected." ], "color_additives": [ "Color additives: no FD&C/D&C colour name was declared on this label" ] }, "advisories": [ { "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "message": "California, Colorado, Connecticut, Illinois, Maine, Minnesota, New Hampshire, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington prohibit or restrict intentionally added PFAS in cosmetics; effective dates vary by state and each state's own finding gives its date. These are class-wide bans, so a label-text scan cannot certify the absence of all PFAS, many are undeclared or appear under trade names. No listed PFAS substance was detected on this label. Confirm with your formulator that no PFAS is intentionally added.", "citations": "CA California AB 2771 \u00b7 CO C.R.S. \u00a7\u00a7 25-15-601 to -604 \u00b7 CT Conn. Gen. Stat. 22a-903c \u00b7 IL 410 ILCS 612 \u00b7 ME 38 M.R.S. \u00a71614 \u00b7 MN Minn. Stat. \u00a7 116.943 \u00b7 NH N.H. Rev. Stat. Ann. \u00a7 149-M:64, IV \u00b7 NJ N.J.S.A. 56:3-53 et seq. \u00b7 NM N.M. Per- and Poly-Fluoroalkyl Substances Pr \u00b7 OR Oregon SB 546 \u00b7 RI R.I. Gen. Laws 23-18.18-4 \u00b7 VT 9 V.S.A. \u00a7 2494b \u00b7 WA Chapter 70A.560 RCW", "scope": "formulation" }, { "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "message": "Oregon, Vermont and Washington prohibit intentionally added ortho-phthalates in cosmetics; effective dates vary by state and each state's own finding gives its date. This is a class-wide ban and some ortho-phthalates are undisclosed under \"fragrance\", so a label-text scan cannot certify their absence. No phthalate was detected by name on this label. Confirm your formulation contains no intentionally added ortho-phthalates.", "citations": "OR Oregon SB 546 \u00b7 VT 9 V.S.A. \u00a72494b \u00b7 WA RCW 70A.560.020", "scope": "formulation" }, { "code": "PKG.toxics_in_packaging", "citation_url": "https://www.toxicsinpackaging.org", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "scope": "formulation", "message": "Nineteen states have adopted the CONEG/TPCH Toxics in Packaging model law (count per the Toxics in Packaging Clearinghouse fact sheet, rev. Nov 2023). These limit lead, cadmium, mercury and hexavalent chromium in a package or packaging component to 100 parts per million by weight, stated as a combined total in every one of them except Iowa, whose text says only 'the concentration levels'. Five are verified against primary text: Florida (Fla. Stat. 403.7191(3)), Iowa (Iowa Code 455D.19(3)-(4)), Missouri (RSMo 260.822), Pennsylvania (Safe Packaging Act, Act of Dec. 7, 1994, P.L. 797, No. 112, sec. 301), Wisconsin (Wis. Stat. 100.285(2)). Georgia (O.C.G.A. 12-8-162) is included on a secondary reproduction only, not the official code. The 100 ppm tier is in force in all six. NOTE Wisconsin attaches NO PENALTY to its limit (Wis. Stat. 100.285(5)). Only PENNSYLVANIA prohibits INTENTIONAL introduction outright regardless of concentration; Georgia and Iowa carry that clause but gate it on also exceeding the agency-set level, and Florida, Wisconsin and Missouri have no such clause at all. SCOPE: this regulates the PACKAGE, expressly including inks, labels, coatings and closures, NOT the product formula. It therefore cannot be verified or violated by label text, and this scan does not check it.", "suggested_fix": "Request a Certificate of Compliance from your packaging and label printers stating that the carton, label, inks, coatings and closure meet the CONEG/TPCH 100 ppm limit for total lead, cadmium, mercury and hexavalent chromium. That document is per component, not a label change. Note that in Florida, Georgia, Missouri and Pennsylvania the prohibition also reaches whoever offers the PRODUCT for sale, so as the brand owner you are a regulated party yourself, not merely a purchaser relying on your printer's paperwork." }, { "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "citation_url": "https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=111792", "scope": "formulation", "message": "California Safe Cosmetics Program (CSCP): if your company's annual cosmetic sales exceed $1M AND this product contains any chemical on the CDPH Reportable Ingredients List (thousands of chemicals across 22 hazard lists, Prop 65, IARC, NTP, EPA, and EU classifications), you must report it to CDPH at cscpsubmit.cdph.ca.gov. This is a corporate reporting obligation, not an on-label requirement, and it cannot be determined from label text alone, it does not affect whether this label is compliant. Verify your reporting status with CDPH if the revenue threshold applies." }, { "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "citation_url": "https://dec.ny.gov/environmental-protection/pollution-prevention/household-personal-cosmetic-dioxane-limits", "scope": "formulation", "message": "New York caps 1,4-dioxane at 10 ppm in cosmetics and 1 ppm in personal care products (ECL Article 37 Title 1, \u00a7 37-0117(3)-(4); 6 NYCRR Subpart 352-1). It is a manufacturing impurity of ethoxylated ingredients (PEGs, -eth- surfactants, polysorbates), never a declared ingredient, so a label scan cannot verify the threshold. If your formula uses ethoxylated ingredients, obtain a 1,4-dioxane test report from your supplier, rinse-off personal care products face the tighter 1 ppm limit." }, { "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "citation_url": "https://www.revisor.mn.gov/statutes/cite/325E.3892", "scope": "formulation", "message": "Minnesota caps lead at 90 ppm and cadmium at 75 ppm by total weight in cosmetics and personal care products (Minn. Stat. \u00a7 325E.3892). These are total-content limits, not declared-ingredient limits: colorant and pigment impurities can carry either metal below declaration level. No lead or cadmium compound is declared on this label, but a label scan cannot verify total content - obtain a heavy-metals certificate of analysis from your pigment and raw-material suppliers." }, { "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "citation_url": "https://legislature.vermont.gov/statutes/section/09/063/02494b", "scope": "formulation", "message": "Vermont Act 131 (9 V.S.A. \u00a72494b, eff. Jan 1, 2026) bans 1,4-dioxane (>=10 ppm) and asbestos. These are typically undeclared contaminants (dioxane an impurity, asbestos a talc contaminant), so a label scan cannot certify their absence and the 10 ppm dioxane threshold is not verifiable from text. Confirm via supplier documentation / testing that 1,4-dioxane is below 10 ppm and no asbestos is present." }, { "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "citation_url": "https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html", "scope": "formulation", "message": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility." }, { "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "citation_url": "https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/SB546/Enrolled", "scope": "formulation", "message": "Oregon SB 546 formaldehyde-releasing-agent ban (eff. Jan 1, 2027): SB 546 \u00a74 bans this category generically (no statutory list). The scan checks a representative set of common formaldehyde donors; a no-match does not certify absence of every releasing agent. Before Jan 1, 2027 confirm your preservation system releases no formaldehyde (Oregon SB 546, \u00a74)." }, { "code": "IH.restricted_preservative.phenoxyethanol", "scope": "formulation", "detected": "yes", "severity": "warning", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "message": "Phenoxyethanol is on our watch list, but NO US federal or state rule we screen restricts it in cosmetics today, so this is not a violation and nothing on your label has to change because of it. Phenoxyethanol is flagged as a potential hazard (restricted preservative). Widely used cosmetic preservative. EU Annex V Entry 29: maximum 1.0%; no product-type restriction. Japan: 1.0% maximum in cosmetics under MHLW regulation. US: No 21 CFR prohibition. FDA issued a product-specific consumer warning in 2008 concerning Mommy's Bliss Nipple Cream containing phenoxyethanol + chlorphenesin, phenoxyethanol can depress the CNS and cause vomiting and diarrhea in infants via direct nipple-cream exposure. NOT a general FDA advisory on phenoxyethanol. Not Prop 65 listed. Flagged under some clean beauty retailer standards. Raise it with your formulator if the concern matters for your product or your retailer's own standards.", "suggested_fix": "No action is required to comply with US law. Check with your formulator whether to keep the ingredient, and confirm your retailer's own standards if you sell into a program that screens it.", "source_url": "" }, { "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "message": "Amazon's cosmetics listing requirements ask that units display identifying codes such as lot or serial numbers, and an expiration date for products with a shelf life under three years or otherwise a period-after-opening symbol such as '12M'. A lot code is usually a fill-line inkjet or laser mark and the PAO symbol is a pictogram, so neither can be verified from label text; this note appears on every Amazon check rather than reporting a false absence. Amazon's own cosmetics help page is behind a Seller Central sign-in.", "suggested_fix": "Confirm with your filler that each unit carries a lot or serial code, and that products with a shelf life under three years carry an expiration date (otherwise a PAO symbol such as 12M).", "detected": false, "evidence": null, "source_url": "https://sellercentral.amazon.com/help/hub/reference/external/200164470", "programme": null, "retailer": "amazon", "scope": "formulation" } ], "claims_risks": [ { "code": "CLM.drug_treats", "title": "Drug claim: 'treats' a condition", "description": "The word 'treats' applied to a skin or medical condition constitutes a drug claim under FDA guidelines. Cosmetics cannot treat diseases or conditions.", "severity": "error", "claim_text": "Treats eczema", "risk_type": "drug_claim", "suggested_fix": "Remove this claim, it cannot be used for cosmetics regardless of documentation. Replace with: 'helps the appearance of', 'soothes the look of', or 'minimizes the visible signs of'.", "substantiation_type": null, "claim_category": "prohibited", "rewrite_action": "rewrite", "compliant_rewrite": "soothes and improves the look of skin", "compliant_rewrites": [ "soothes and improves the look of skin", "visibly comforts the look of stressed skin", "leaves skin feeling calm and comfortable", "formulated for skin that needs extra care" ], "substantiation_needed": null, "claim_scope": null, "remediation": { "title": "Drug claim: 'treats' a condition", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Marketing claims", "what_we_detected": "We found the claim \"Treats eczema\".", "why_it_matters": "The word 'treats' applied to a skin or medical condition constitutes a drug claim under FDA guidelines. Cosmetics cannot treat diseases or conditions.", "rule": "CLM.drug_treats", "authority": null, "citation": null, "citation_url": null, "recommended_action": "Remove this claim, it cannot be used for cosmetics regardless of documentation. Replace with: 'helps the appearance of', 'soothes the look of', or 'minimizes the visible signs of'.", "compliant_example": "soothes and improves the look of skin", "example_is_placeholder": false, "confidence": null, "confidence_basis": null, "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1, "display_title": "Drug claim: 'treats' a condition" }, { "code": "CLM.drug_cures", "title": "Drug claim: 'cures' or 'heals'", "description": "'Cures' and 'heals' are drug claims. FDA classifies products that cure or heal disease as drugs, not cosmetics.", "severity": "error", "claim_text": "cures acne", "risk_type": "drug_claim", "suggested_fix": "Remove this claim, it cannot be used for cosmetics regardless of documentation. Replace with: 'improves the appearance of', 'helps skin look healthier'.", "substantiation_type": null, "claim_category": "prohibited", "rewrite_action": "rewrite", "compliant_rewrite": "helps skin look and feel healthier", "compliant_rewrites": [ "helps skin look and feel healthier", "improves the look of skin over time", "leaves skin feeling softer and more comfortable", "a daily formula for skin comfort" ], "substantiation_needed": null, "claim_scope": null, "remediation": { "title": "Drug claim: 'cures' or 'heals'", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Marketing claims", "what_we_detected": "We found the claim \"cures acne\".", "why_it_matters": "'Cures' and 'heals' are drug claims. FDA classifies products that cure or heal disease as drugs, not cosmetics.", "rule": "CLM.drug_cures", "authority": null, "citation": null, "citation_url": null, "recommended_action": "Remove this claim, it cannot be used for cosmetics regardless of documentation. Replace with: 'improves the appearance of', 'helps skin look healthier'.", "compliant_example": "helps skin look and feel healthier", "example_is_placeholder": false, "confidence": null, "confidence_basis": null, "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1, "display_title": "Drug claim: 'cures' or 'heals'" }, { "code": "CLM.condition_eczema", "title": "Drug claim: names eczema / dermatitis", "description": "Marketing a cosmetic with 'eczema' or 'dermatitis' (including 'eczema-prone') establishes drug intended use under FD&C Act 201(g), a product intended to treat or mitigate a disease is a drug regardless of phrasing. Colloidal-oatmeal skin protectants may claim relief of 'itching due to eczema' only under OTC Monograph M016 (skin protectants) with a Drug Facts panel.", "severity": "error", "claim_text": "eczema", "risk_type": "drug_claim", "suggested_fix": "Remove the condition name. Replace with: 'for dry, itch-prone skin'. Or market as an OTC skin protectant (e.g. colloidal oatmeal monograph) with a compliant Drug Facts panel.", "substantiation_type": null, "claim_category": "prohibited", "rewrite_action": "rewrite", "compliant_rewrite": "for dry, itch-prone skin", "compliant_rewrites": [ "for dry, itch-prone skin", "for skin that looks dry and irritated", "leaves dry skin feeling comfortable", "a rich formula for very dry skin" ], "substantiation_needed": null, "claim_scope": null, "remediation": { "title": "Drug claim: names eczema / dermatitis", "status": "fail", "severity": "error", "priority": 1, "affected_area": "Marketing claims", "what_we_detected": "We found the claim \"eczema\".", "why_it_matters": "Marketing a cosmetic with 'eczema' or 'dermatitis' (including 'eczema-prone') establishes drug intended use under FD&C Act 201(g), a product intended to treat or mitigate a disease is a drug regardless of phrasing. Colloidal-oatmeal skin protectants may claim relief of 'itching due to eczema' only under OTC Monograph M016 (skin protectants) with a Drug Facts panel.", "rule": "CLM.condition_eczema", "authority": null, "citation": null, "citation_url": null, "recommended_action": "Remove the condition name. Replace with: 'for dry, itch-prone skin'. Or market as an OTC skin protectant (e.g. colloidal oatmeal monograph) with a compliant Drug Facts panel.", "compliant_example": "for dry, itch-prone skin", "example_is_placeholder": false, "confidence": null, "confidence_basis": null, "manual_verification": { "required": false, "what_to_verify": null } }, "priority": 1, "display_title": "Drug claim: names eczema / dermatitis" } ], "format_guidance": [ { "requirement": "Professional-use-only products must state they are for use only by licensed professionals", "citation": "21 U.S.C. \u00a7 364e(c) (FD&C Act \u00a7 609)", "what_user_must_do": "If this product is distributed for use only by professionals, add a clear, prominent statement that it is to be used only by licensed professionals (cosmetology, nail care, barbering, or esthetics). A label scan cannot certify whether a product is professional-distribution-only, so confirm this applies to your product.", "can_engine_verify": false, "source_url": "https://uscode.house.gov/view.xhtml?req=(title:21%20section:364e%20edition:prelim)" }, { "requirement": "Net quantity placement and lettering size", "citation": "21 CFR 701.13(e), (f), (i)", "what_user_must_do": "Put the net quantity on the front (principal display) panel, in the bottom 30% of that panel, parallel to the base. The bottom-30% placement requirement does not apply to panels of 5 square inches or less when the other requirements are met. Minimum letter height by panel size: 1/16\" (\u22645 sq in), 1/8\" (>5, 25), 3/16\" (>25, 100), 1/4\" (>100 up to 400), 1/2\" (>400). Add 1/16\" if lettering is blown, embossed, or molded. We can't measure panel size or lettering from text, confirm this on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.13" }, { "requirement": "Clear space around the net quantity statement", "citation": "21 CFR 701.13(f)", "what_user_must_do": "Separate the net quantity from other printed label information above and below by at least the height of its lettering. Leave at least twice the width of its letter N to the left and right. Confirm this on the print artwork; the current PDF checks do not measure this clearance.", "can_engine_verify": false, "source_url": "https://www.ecfr.gov/current/title-21/section-701.13" }, { "requirement": "Statement of identity prominence and placement", "citation": "21 CFR 701.11", "what_user_must_do": "Show what the product is (common name, descriptive name, or an illustration) on the front panel as one of its main features, in bold type, sized in proportion to the most prominent text on that panel. We can't verify size or panel position from text, confirm this on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.11" }, { "requirement": "Ingredients in descending order of predominance", "citation": "21 CFR 701.3(a), (f)", "what_user_must_do": "List ingredients from most to least by amount. Exception: ingredients at 1% or less may appear in any order after those above 1%, and color additives may appear in any order at the end. We can't see your formula's concentrations from the label, so we can't verify the order, confirm it matches your formulation.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Ingredient lettering size / small-package options", "citation": "21 CFR 701.3", "what_user_must_do": "Ingredient lettering must meet the minimum height for your package size. Very small packages may place the ingredient list on a tag, tape, or card firmly affixed to the package, or on accompanying display material. We can't measure this from text, confirm on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Correct panel placement (front panel vs. information panel)", "citation": "21 CFR 701.3, 701.12, 701.13(e)", "what_user_must_do": "Net quantity goes on the front (principal display) panel; the ingredient list and the manufacturer/distributor name and address may go on an information panel. We check that this information is present in your text but can't tell which physical panel it's on, confirm panel placement on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.12" }, { "requirement": "Conspicuousness, contrast, and English", "citation": "21 CFR 701.2", "what_user_must_do": "All required statements must be in English and easy to find and read under normal shopping conditions, adequate type size, good contrast, not crowded. If any required statement also appears in another language, all required statements must appear in that language too. We can't assess size, contrast, or prominence from text; confirm on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.2" }, { "requirement": "Safety-substantiation warning (if applicable)", "citation": "21 CFR 740.10", "what_user_must_do": "If your product's safety has not been adequately substantiated, the front panel must bear, word for word: \"Warning\u2014The safety of this product has not been determined.\" We can't tell from the label whether your safety data is on file, confirm whether this applies.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.10" }, { "requirement": "Tanning / self-tanner warning (if applicable)", "citation": "21 CFR 740.19", "what_user_must_do": "If your product is a suntanning preparation that does not contain a sunscreen, its labeling must display, word for word: \"Warning-This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.\" 21 CFR 740.19 defines \"suntanning preparations\" to include topical products that give a cosmetic effect on the skin while tanning under UV radiation and products that give the appearance of a tan with an approved colour additive such as dihydroxyacetone. We check this automatically when the label names the product as a tanning or self-tanning preparation, or declares dihydroxyacetone. If your product is one and uses wording we did not recognise, confirm this yourself.", "can_engine_verify": false, "source_url": "https://www.ecfr.gov/current/title-21/section-740.19" }, { "requirement": "Aerosol / pressurized-container warnings (if applicable)", "citation": "21 CFR 740.11", "what_user_must_do": "If your product is in a pressurized (aerosol) container, it must bear, word for word: \"Warning\u2014Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 \u00b0F. Keep out of reach of children.\" (Glass: use \"break\" for \"puncture\"; non-spray: omit \"Avoid spraying in eyes\"; children's: add \"except under adult supervision.\") If it uses a halocarbon or hydrocarbon propellant, also: \"Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.\"", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.11" }, { "requirement": "Warning-statement conspicuousness (type size, bold, contrast)", "citation": "21 CFR 740.2", "what_user_must_do": "Every warning statement must appear prominently and conspicuously compared to other words and designs, in bold type on contrasting background, likely to be read under customary conditions of purchase and use - and never in letters or numbers under 1/16 inch in height (unless FDA has granted a small-package exemption by regulation). We can verify a warning's TEXT is present but not its size, weight, or contrast; confirm these on your packaging artwork.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.2" }, { "requirement": "Tamper-resistant packaging for cosmetic liquid oral hygiene and vaginal products (if applicable)", "citation": "21 CFR 700.25", "what_user_must_do": "If this product is a cosmetic liquid oral hygiene product or a cosmetic vaginal product, and it is accessible to the public while held for sale, it must be packaged in a tamper-resistant retail package. Except for aerosol products, the retail package must also bear a statement, prominently placed, that alerts consumers to the specific tamper-resistant feature. (An oral-hygiene product marketed with a therapeutic claim is an OTC drug, not a cosmetic, and is covered by 21 CFR 211.132 instead.) A label-text scan cannot verify packaging, so confirm whether this applies to your product.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/700.25" }, { "requirement": "No prohibited cattle (BSE) materials in the formulation (if applicable)", "citation": "21 CFR 700.27", "what_user_must_do": "No cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials: specified risk materials, the small intestine of all cattle (unless the distal ileum has been removed by the procedure the regulation specifies), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef. The definition expressly EXCLUDES tallow containing no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, so most common bovine-derived cosmetic ingredients fall outside the ban. If your formula uses any other bovine-derived ingredient, confirm its sourcing with your supplier. A label scan cannot verify ingredient sourcing.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/700.27" }, { "requirement": "Ingredient declaration on multiunit and multicomponent packages (if applicable)", "citation": "21 CFR 701.3(q); 21 CFR 701.3(i)-(k)", "what_user_must_do": "21 CFR 701.3(q): the inside containers of a multiunit or multicomponent package need no ingredient declaration when the outer package bears one that meets this section and the inner units are not sold separately. Separately, 701.3(i)-(k) let a package with less than 12 square inches of label surface carry its declaration on a firmly affixed tag, tape or card, or in leaflet labeling on a display unit or chart; such a display unit must carry the words \"Federal law requires ingredient lists to be displayed here\" in letters not less than 3/16 inch high, conspicuous when no lists remain. Not applicable if the individual units' ingredient declarations are already visible through or on the display package. A label-text scan of a single product panel cannot tell whether this product is sold as part of such a display package.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "\"New ingredient list\" overlabeling notice on formulation changes (if applicable)", "citation": "21 CFR 701.3(n)", "what_user_must_do": "21 CFR 701.3(n) is a permission, not a general overlabel duty: when a shortage of a cosmetic ingredient forces a formulation change, packages already printed with the old declaration may still be used if the revised declaration appears either on a firmly affixed tag, tape, card or sticker bearing the conspicuous words \"new ingredient list\" in letters not less than 1/16 inch high, or on labeling inside an unsealed package whose outside bears \"new ingredient list inside\". Not applicable to a label being printed for the first time. A label-text scan cannot tell whether this PDF is such an overlabel.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "\"May contain\" color additive declaration for batch color-matching (if applicable)", "citation": "21 CFR 701.3(g)(1)", "what_user_must_do": "If a color additive is added to only SOME batches of this product for the purpose of color matching, you may declare it using the phrase \"may contain\" (e.g. \"May Contain: Red 33\") instead of listing it as though every batch contains it. This is an OPTIONAL labeling accommodation - a label that lists every color additive unconditionally is also compliant. A label-text scan cannot tell whether a given batch actually varies this way; confirm with your formulator which additives are batch-variable before using this declaration style.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Composite color-additive list for an assortment sold in one package (if applicable)", "citation": "21 CFR 701.3(h)", "what_user_must_do": "If this product ships as part of an assortment of cosmetics sold together in the same package, you may declare the COLOR ADDITIVES of the whole assortment in a single composite list - instead of a separate color-additive declaration for each product - as long as the listing is not misleading and makes clear it covers every product in the package. This applies to color additives only; the rest of the ingredient declaration follows the ordinary rules. A label-text scan of one product panel cannot tell whether it ships packaged together with others.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Cumulative ingredient list for an assortment of similar products (if applicable)", "citation": "21 CFR 701.3(o)", "what_user_must_do": "If this product is sold as part of an assortment of products similar in composition and intended for the same use (FDA's example is an eyeshadow palette), you may declare the ingredients common to all of them in a single cumulative list, together with a statement identifying which products contain the other, non-common ingredients - or, if the package's labelable surface is under 12 square inches, in one combined list with no separate non-common statement required. A label-text scan of one product panel cannot tell whether it ships as part of such an assortment.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Shared label declaration for a branded shade line (if applicable)", "citation": "21 CFR 701.3(g)(2), (o)(3)-(4)", "what_user_must_do": "If this product is one item in a branded shade line sold under a common trade name with no other brand appearing on any item (FDA's examples: one lipstick in a line of lipsticks, or one compact in a line of compacts), the line may share a single label declaring the ingredients common to all shades, plus a statement identifying the other, shade-specific ingredients and which product(s) contain them; shade-specific color additives may use the \"may contain\" declaration under 701.3(g)(2). A label-text scan of one shade's panel cannot tell whether it is part of such a line.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Direct-mail alternative ingredient declaration (if applicable)", "citation": "21 CFR 701.3(r)", "what_user_must_do": "If this product is sold to consumers by direct mail, the ingredient declaration may appear (letters not less than 1/16 inch high) in the accompanying mailing, sales catalog, or brochure instead of on the package, PROVIDED the mailed package itself carries a notice - visible on opening, letters not less than 3/16 inch high - that states where the declaration is located, promises a copy will be mailed promptly on request, and gives the mail-order distributor's name and place of business; the distributor must then actually fulfill that promise when asked. A label-text scan of the package panel cannot tell whether this product is sold by direct mail or whether the required catalog/brochure declaration exists.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Off-package leaflet ingredient declaration for small/compartmented display units (if applicable)", "citation": "21 CFR 701.3(i)-(k)", "what_user_must_do": "If this product's package has under 12 square inches of labelable surface (and is not enclosed in an outer carton), the ingredient declaration may instead appear (letters not less than 1/16 inch high) on an accompanying leaflet attached to a compartmented display tray or rack - or, for a shade-matched assortment, attached to a display chart bearing shade samples - rather than on each unit. Strict conditions apply: the leaflet must be visible per specific placement rules (fully readable from the front, or accompanied by a 3/16-inch notice if partially visible or on a side); all copies used with one display must be identical; the unit must ship together with its labeling; the display must show \"Federal law requires ingredient lists to be displayed here\" (3/16 inch minimum) whenever no declaration is currently attached; a formulation change requires the leaflet to be dated and to distinguish old vs. new formula; sufficient copies must be provided for every purchaser; and the firm named on the product must mail a copy to anyone who requests one. A label-text scan of one product's panel cannot tell whether it is sold this way or whether the display unit meets these conditions.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "CPSIA lead and phthalate limits for children's cosmetics/packaging (if applicable)", "citation": "15 U.S.C. \u00a7 1278a; 16 CFR 1303.2; 16 CFR 1307.2-.3", "what_user_must_do": "If this product, its packaging, or an accessory (e.g. an applicator) is a children's product as defined by the CPSIA, or has any paint or similar surface coating, two federal chemical limits apply: (1) total lead content in any accessible substrate material may not exceed 100 ppm (15 U.S.C. \u00a7 1278a), and lead in paint or similar surface coatings may not exceed 0.009% / 90 ppm (16 CFR 1303.2); (2) a children's toy or child care article may not contain more than 0.1% of any of eight prohibited phthalates - DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP (16 CFR 1307.2-.3) - applying equally to toys and child care articles, no mouth-contact or age distinction. DIDP and DnOP, part of the ORIGINAL 2008 interim ban, are NOT on the current permanent list and are not restricted by this rule today. These are formula/material composition facts a label-text scan cannot see - confirm testing with your supplier if this product is marketed to or usable by children.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/16/1307.3" }, { "requirement": "Country-of-origin marking for imported product (if applicable)", "citation": "19 U.S.C. \u00a7 1304(a)", "what_user_must_do": "If this product is of foreign origin, the ARTICLE itself - not merely the shipping carton - must be marked in a conspicuous place, as legibly, indelibly and permanently as the nature of the article will permit, with the English name of the country of origin, for example \"Made in France\". We raise a specific finding automatically only when the label carries a non-US address and we find no origin mark on it. Whether the product is in fact imported, and whether the physical marking is conspicuous, indelible and permanent enough, are facts about the finished package that a label-text scan cannot determine, so confirm both with your manufacturer. If the article is made in the United States, this statute requires no marking.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/uscode/text/19/1304" } ], "unsupported_reasons": [], "supplier_documents": [], "retailer_document_kits": { "amazon": [ { "name": "Supplier or manufacturer invoice dated within the last 180 days", "why": "Amazon requires a recent invoice to establish an authentic chain of custody for the product.", "conditional": false }, { "name": "Certificate of Analysis (COA) from an accredited lab", "why": "Provides test evidence for the substances and limits actually tested. Check the lot, method, scope and retailer request; it is not a blanket compliance certificate.", "conditional": false }, { "name": "Good Manufacturing Practice (GMP) certificate", "why": "Provides evidence about the manufacturing practices covered by the certificate or audit. Confirm its scope, validity and the retailer's requirements.", "conditional": false }, { "name": "Full INCI ingredient list matching the corrected label", "why": "Amazon cross-checks the declared ingredients against its restricted-substances list.", "conditional": false }, { "name": "Safety Data Sheet (SDS) for the finished formulation", "why": "Standard safety documentation reviewers request for cosmetics.", "conditional": false }, { "name": "Clear photos of the corrected packaging and label (all panels)", "why": "Restricted-products reviews accept corrected-label photos as primary evidence that the issue is fixed.", "conditional": false }, { "name": "FDA OTC drug registration + NDC number (Forms FDA 2657 / 2656)", "why": "Required for any product making an OTC drug claim (SPF/sunscreen, acne, antiperspirant, antibacterial).", "conditional": false }, { "name": "Proof of California Safe Cosmetics Program (CSCP) reporting", "why": "Requested when the product is sold into California and contains a reportable ingredient.", "conditional": true } ] }, "zones": [ { "kind": "pdp", "basis": "leading_block", "start": 0, "end": 60, "excerpt": "Radiance Face Serum\nTreats eczema and cures acne overnight." }, { "kind": "ingredients", "basis": "header", "header": "Ingredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol.", "start": 60, "end": 123, "excerpt": "Ingredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol." }, { "kind": "directions", "basis": "header", "header": "Directions: Apply a small amount to clean skin.", "start": 123, "end": 171, "excerpt": "Directions: Apply a small amount to clean skin." }, { "kind": "manufacturer", "basis": "header", "header": "Manufactured by Example Beauty, Austin, TX", "start": 171, "end": 213, "excerpt": "Manufactured by Example Beauty, Austin, TX" } ], "concentration_notes": [], "semantic_findings": [], "semantic_status": "disabled", "label_id": 1, "scan_id": 1, "created_at": "2026-09-15 13:16:30", "workflow_state": "needs_edits", "version_number": 1, "auto_tasks_created": 10, "ocr_provider": null, "ocr_confidence": null, "checks_performed": [ { "code": "701.11.identity_present", "title": "Identity statement present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.13.net_quantity_present", "title": "Net quantity of contents present", "status": "error", "category": "federal", "evaluation_state": "fail" }, { "code": "701.3.ingredients_heading", "title": "Ingredient declaration present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.12.manufacturer_present", "title": "Manufacturer or distributor present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "warnings.eye_contact", "title": "Eye-contact warning (best practice)", "status": "warning", "category": "federal", "evaluation_state": "warning" }, { "code": "warnings.children_best_practice", "title": "Children safety warning (best practice)", "status": "warning", "category": "federal", "evaluation_state": "warning" }, { "code": "701.2.english_required", "title": "Required information appears in English", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "warnings.flammable", "title": "Flammability warning if applicable", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.aha_warning", "title": "AHA sun sensitivity warning recommended", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.prostaglandin_lash", "title": "Prostaglandin analog in a lash or brow product: unapproved prescription drug", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.salicylic_acid_acne", "title": "Salicylic acid above 2% in an acne product: unapproved new drug", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.anesthetic_active", "title": "Anesthetic active declared without a Drug Facts panel", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.kohl_kajal_surma", "title": "FDA prohibited: kohl, kajal, al-kahal or surma", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.marine_mammal_derived", "title": "Cetacean-derived ingredient: prohibited from US commerce", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "MBFWA.microbeads_prohibited", "title": "Plastic microbeads prohibited in rinse-off cosmetics", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.bithionol", "title": "FDA prohibited ingredient: Bithionol", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.chloroform", "title": "FDA prohibited ingredient: Chloroform", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.halogenated_salicylanilides", "title": "FDA prohibited ingredient: Halogenated salicylanilides", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.methylene_chloride", "title": "FDA prohibited ingredient: Methylene chloride", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.vinyl_chloride", "title": "FDA prohibited ingredient: Vinyl chloride", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.cfc_propellants", "title": "FDA prohibited ingredient: Chlorofluorocarbon propellants", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.restricted.zirconium_aerosol", "title": "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "FDA.restricted.hexachlorophene", "title": "FDA restricted ingredient: Hexachlorophene", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "FDA.restricted.mercury", "title": "FDA restricted ingredient: Mercury compounds", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "COLOR.unapproved_additive", "title": "Color additive not on the FDA approved lists", "status": "pass", "category": "color_additives", "evaluation_state": "pass" }, { "code": "COLOR.fdc_red_3_terminated", "title": "FD&C Red No. 3 - cosmetic listing terminated", "status": "pass", "category": "color_additives", "evaluation_state": "pass" }, { "code": "warnings.external_use_only", "title": "'For external use only' warning recommended (best practice)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing chemical actives that warrant an external-use statement. None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "warnings.discontinue_if_irritation", "title": "'Discontinue use if irritation occurs' warning recommended (best practice)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing strong actives (retinol, salicylic acid, benzoyl peroxide and similar). None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "warnings.hair_dye_warning", "title": "Coal-tar hair dye caution required (FD&C Act \u00a7 601 / 21 U.S.C. \u00a7 361)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to coal-tar hair dye products. No hair dye ingredient (p-phenylenediamine, resorcinol, aminophenol) is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "detergent_label", "title": "Eye contact warning recommended for surfactant-based product", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to surfactant-based products. No surfactant (SLS, SLES, cocamidopropyl betaine) is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.feminine_deodorant_caution", "title": "Feminine deodorant spray mandatory caution (21 CFR 740.12(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to feminine deodorant sprays (21 CFR 740.12). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.feminine_hygiene_term", "title": "\"Hygiene\" wording barred on feminine deodorant sprays (21 CFR 740.12(c))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to feminine deodorant sprays (21 CFR 740.12). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.foaming_bath_caution", "title": "Foaming/bubble bath mandatory caution (21 CFR 740.17(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to foaming/bubble bath products (21 CFR 740.17). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.tamper_evident_statement", "title": "Tamper-resistant packaging statement (21 CFR 700.25)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetic liquid oral hygiene products (mouthwash, oral rinse) and vaginal products (21 CFR 700.25), and only when they are cosmetics. Either this label does not represent the product as either -- toothpaste is not a LIQUID oral hygiene product and is outside the regulation -- or the label carries a Drug Facts panel, in which case the product is an OTC drug and the equivalent tamper-evident packaging duty sits at 21 CFR 211.132 instead. That is the authority to work from. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_term_qualifier", "title": "\"Sunscreen\" terminology on a cosmetic must be qualified (21 CFR 700.35)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetic labels that use the term \"sunscreen\" or similar sun-protection terminology without SPF/Drug Facts labeling. This label does not. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.suntanning_warning", "title": "Suntanning preparation warning without a sunscreen (21 CFR 740.19)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to suntanning and self-tanning preparations (21 CFR 740.19). This label does not represent the product as one and declares no dihydroxyacetone. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.self_pressurized_warning", "title": "Self-pressurized (aerosol) container warning (21 CFR 740.11(a))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetics packaged in a self-pressurized (aerosol) container (21 CFR 740.11). Nothing on this label indicates a pressurized container or a propellant. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.aerosol_propellant_misuse_warning", "title": "Aerosol propellant intentional-misuse warning (21 CFR 740.11(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to self-pressurized products whose propellant is a halocarbon or a hydrocarbon (21 CFR 740.11(b)). No such propellant is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.13.parenthetical_restatement", "title": "Net quantity \u2265 1 lb / 1 pt needs a parenthetical restatement (21 CFR 701.13(j)(1))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to a net quantity declared in US customary units (ounces, fluid ounces, pounds, pints, or quarts) (21 CFR 701.13(j)(1)). No US-customary declaration was found on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.13.fraction_form", "title": "Net quantity fraction denominator (21 CFR 701.13(d))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to a net quantity declared in US customary units (21 CFR 701.13(d)). No US-customary declaration was found on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.13.abbreviation_form", "title": "Net quantity abbreviation form (21 CFR 701.13(n))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to a net quantity declared in US customary units (21 CFR 701.13(n)). No US-customary declaration was found on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.13.exaggerating_qualifier", "title": "Net quantity exaggerating qualifier (21 CFR 701.13(q); 15 U.S.C. \u00a7 1453(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to a net quantity declared in US customary units (21 CFR 701.13(q); 15 U.S.C. \u00a7 1453(b)). No US-customary declaration was found on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.2.english_required_elements", "title": "Required label element appears in Spanish but not English (21 CFR 701.2(b)(1))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.12.manufacturer_address_incomplete", "title": "Manufacturer place of business is missing the ZIP code", "status": "warning", "category": "federal", "evaluation_state": "warning" }, { "code": "FPLA.net_quantity_format", "title": "Net quantity states both US customary and metric units (15 U.S.C. \u00a7 1453(a)(2))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This check judges the units of the net quantity statement (15 U.S.C. \u00a7 1453(a)(2)) and this label carries no net quantity statement; the separate presence check reports that. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.3.ingredients_comma_separated", "title": "Ingredient list uses the standard comma-separated format (21 CFR 701.3(a))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.2.foreign_language_consistency", "title": "Required label information appears in any foreign language used (21 CFR 701.2(b))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "EPA.hcfc_ozone_warning", "title": "Ozone-depletion warning present for HCFC-containing products (40 CFR 82.106)", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "CA.prop65.required", "title": "California Prop 65 warning may be required", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.prop65.warning_format", "title": "Prop 65 warning does not match the safe-harbor format", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CA.pfas_restriction", "title": "California PFAS prohibition in cosmetics (AB 2771)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CA.ab2762.sale_ban", "title": "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "MD.hb643.named_ban", "title": "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b", "title": "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.monomers", "title": "Banned for sale in California (2027): styrene / vinyl acetate monomer", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980c.musk_ketone", "title": "Musk ketone capped in California (2027): concentration limits by product type", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.boron", "title": "Banned for sale in California (2027): boron compounds (boric acid / borates)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.laurus_seed", "title": "Banned for sale in California (2027): Laurus nobilis seed oil", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WI.mercury_prohibition", "title": "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "LA.mercury_limit", "title": "Louisiana mercury limit in cosmetics (10 ppm)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NY.mercury_restriction", "title": "New York mercury prohibition in cosmetics", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NY.hair_relaxer_warning", "title": "New York hair-relaxer carcinogen warning (takes effect May 21, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "MN.pfas_restriction", "title": "Minnesota PFAS restriction in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "MN.mercury_prohibition", "title": "Minnesota mercury prohibition in cosmetics, toiletries and fragrances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "MN.childrens_formaldehyde_ban", "title": "Minnesota formaldehyde ban in children's products (under age 8)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "WA.toxic_free_cosmetics", "title": "Washington Toxic-Free Cosmetics Act", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WA.toxic_free_cosmetics.ortho_phthalate_class", "title": "Washington ortho-phthalate class ban in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "WA.pfas_restriction", "title": "Washington PFAS restriction in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NJ.pfas_restriction", "title": "New Jersey PFAS class ban in cosmetics (takes effect Jan 12, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CT.pfas_restriction", "title": "Connecticut PFAS restriction in cosmetics (label-and-notify since Jul 1, 2026; full ban Jan 1, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "RI.pfas_restriction", "title": "Rhode Island PFAS class ban in cosmetics (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "WA.formaldehyde_releasers", "title": "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WA.formaldehyde_releasers.timonacic_straightener", "title": "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "CO.pfas_restriction", "title": "Colorado PFAS prohibition in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CO.hair_relaxer_warning", "title": "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "MD.pfas_restriction", "title": "Maryland PFAS prohibition in cosmetics (HB 643)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "ME.pfas_restriction", "title": "Maine PFAS prohibition in cosmetics (LD 1537)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.pfas_restriction", "title": "Vermont PFAS prohibition in cosmetics (S.25 / Act 131)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.sale_ban", "title": "Banned for sale in Vermont: Act 131 named substances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "VT.act131.ortho_phthalate_class", "title": "Vermont Act 131 ortho-phthalate class ban", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.2027", "title": "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "HI.environmental_disclosure", "title": "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "status": "advisory", "category": "state", "reason": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility.", "evaluation_state": "advisory" }, { "code": "OR.sb546.sale_ban", "title": "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "OR.sb546.ortho_phthalate_class", "title": "Oregon SB 546 ortho-phthalate class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "OR.sb546.pfas_restriction", "title": "Oregon SB 546 PFAS class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NM.pfas_restriction", "title": "New Mexico PFAS class ban in cosmetics (takes effect Jan 1, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "IL.cosmetics_act.named_ban", "title": "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "IL.pfas_restriction", "title": "Illinois PFAS ban in cosmetics (13 enumerated Jul 1, 2028; whole class Jan 1, 2032)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "IL.mercury_prohibition", "title": "Illinois mercury prohibition in cosmetics, toiletries and fragrances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "AR.hair_relaxer_warning", "title": "Arkansas hair-relaxer carcinogen warning (in force since 2025)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "VA.toxin_free.named_ban", "title": "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "VA.pfas_restriction", "title": "Virginia PFAS prohibition in cosmetics (HB 122)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NH.pfas_restriction", "title": "New Hampshire PFAS prohibition in cosmetics (2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CLM.drug_treats", "title": "Drug claim: 'treats' a condition", "status": "error", "category": "claims", "evaluation_state": "fail" }, { "code": "CLM.drug_cures", "title": "Drug claim: 'cures' or 'heals'", "status": "error", "category": "claims", "evaluation_state": "fail" }, { "code": "CLM.antibacterial", "title": "Drug claim: antibacterial / antimicrobial", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.antiseptic", "title": "Drug claim: antiseptic", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.antifungal", "title": "Drug claim: antifungal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_repellent", "title": "Pesticide claim: insect/pest repellent", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_disinfectant", "title": "Pesticide/drug claim: disinfects or sanitizes", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_mold", "title": "Pesticide claim: kills or prevents mold/mildew", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.anti_dandruff", "title": "Drug claim: anti-dandruff", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.spf_no_drug_facts", "title": "SPF claim requires Drug Facts panel", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.acne_treatment", "title": "Drug claim: acne treatment", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.dna_repair", "title": "Drug claim: DNA repair", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.prevents_hair_loss", "title": "Drug claim: hair loss prevention / regrowth", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.wound_healing", "title": "Drug claim: wound healing", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.collagen_stimulation", "title": "Drug claim: stimulates collagen or elastin", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.anti_inflammatory", "title": "Drug claim: anti-inflammatory", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.clinically_proven", "title": "Substantiation required: 'clinically proven / tested'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.quantified_performance", "title": "Substantiation required: quantified performance claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.procedure_comparison", "title": "Substantiation required: comparison to a medical procedure", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.dermatologist_approved", "title": "Substantiation required: dermatologist claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.expert_professional_recommended", "title": "Substantiation required: physician / medical-professional endorsement claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.hundred_percent_natural", "title": "Advisory: '100% natural': no regulatory standard", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.organic_uncertified", "title": "Substantiation required: 'organic' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.reef_safe", "title": "Substantiation required: 'reef safe'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_general", "title": "Substantiation required: general environmental benefit claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_biodegradable", "title": "Substantiation required: 'biodegradable'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_compostable", "title": "Substantiation required: 'compostable'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_recyclable", "title": "Substantiation required: 'recyclable' / recycled content", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_nontoxic", "title": "Substantiation required: 'non-toxic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_ozone", "title": "Substantiation required: 'ozone-safe' / 'ozone-friendly'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_carbon", "title": "Substantiation required: carbon-neutral / net-zero claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_sustainable", "title": "Substantiation required: 'sustainable' / renewable materials", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_certification_seal", "title": "Substantiation required: third-party certification / seal claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.certified_nontoxic_seal", "title": "Substantiation required: \"Certified Non-Toxic\" / safety-certification seal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.safe_for_children", "title": "Substantiation required: \"safe for kids/tweens/teens\"", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.refillable", "title": "Substantiation required: 'refillable' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.renewable_energy", "title": "Substantiation required: renewable energy claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.free_of_unassociated_substance", "title": "'Free-of' claim names a substance never associated with this product type", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.made_in_usa", "title": "Substantiation required: 'Made in USA'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.cruelty_free", "title": "Substantiation required: 'cruelty-free' / 'not tested on animals'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.vegan", "title": "Substantiation required: 'vegan'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.gluten_free", "title": "Substantiation required: 'gluten-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.gmo_free", "title": "Substantiation required: 'non-GMO' / 'GMO-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.unscented", "title": "Substantiation required: 'unscented' (not the same as fragrance-free)", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.award_winning", "title": "Substantiation required: award / best-seller claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.usda_organic_seal", "title": "Substantiation required: 'USDA Organic' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.fda_approved_cosmetic", "title": "False claim: 'FDA approved' for a cosmetic", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.eliminates_permanently", "title": "Drug claim: 'eliminates' or 'permanently' + skin condition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.hypoallergenic", "title": "Substantiation required: 'hypoallergenic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.non_comedogenic", "title": "Substantiation required: 'non-comedogenic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_eczema", "title": "Drug claim: names eczema / dermatitis", "status": "error", "category": "claims", "evaluation_state": "fail" }, { "code": "CLM.condition_psoriasis", "title": "Drug claim: names psoriasis", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_rosacea", "title": "Drug claim: names rosacea", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_melasma", "title": "Drug claim: names melasma / chloasma", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_keratosis", "title": "Drug claim: names keratosis (incl. keratosis pilaris)", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_barrier_repair", "title": "Drug claim: repairs / rebuilds the skin barrier", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_cell_regeneration", "title": "Drug claim: regenerates cells / cell renewal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.prescription_strength", "title": "Drug claim: prescription / Rx-strength", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.comparative_prescription", "title": "Drug claim: compares efficacy to prescription products", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.medical_grade", "title": "Misleading: 'medical-grade' / 'cosmeceutical'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_detox", "title": "Misleading: 'detoxifies' skin", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.timeframe_results", "title": "Substantiation required: results within a stated timeframe", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.skin_bleaching", "title": "Drug claim: skin whitening / bleaching / lightening", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_vitiligo", "title": "Drug claim: names vitiligo", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_warts", "title": "Drug claim: names warts", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_cold_sore", "title": "Drug claim: names cold sores / herpes", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_fungal", "title": "Drug claim: names a fungal condition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_lice", "title": "Drug claim: head lice / pediculicide", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.oral_anticaries", "title": "Drug claim: cavity / tooth-decay / gingivitis prevention", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pore_shrink", "title": "Misleading: shrinks / tightens pores", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.cellulite", "title": "Misleading: reduces / eliminates cellulite", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.uv_protection", "title": "Drug claim: UV / sun protection without sunscreen drug labeling", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.lash_growth", "title": "Drug claim: eyelash or eyebrow growth", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.scar_treatment", "title": "Drug claim: treats or removes scars", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.stretch_mark_treatment", "title": "Drug claim: removes or prevents stretch marks", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.topical_anesthetic", "title": "Drug claim: numbing or pain relief", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.reverses_aging", "title": "Drug claim: reverses aging or sun damage", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.chemical_free", "title": "Misleading: 'chemical-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.clean_beauty", "title": "Advisory: 'clean' has no regulatory definition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.anti_pollution", "title": "Substantiation required: anti-pollution / blue-light protection", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "FDA.unapproved_otc_drug", "title": "Not-GRASE active ingredient: unapproved new drug under FD&C 505(a)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing an OTC drug active ingredient. None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_not_grase", "title": "Not-GRASE sunscreen active: not legally marketable under OTC monograph", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to OTC sunscreen products. No sunscreen active ingredient is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_cat3_pending", "title": "Chemical sunscreen actives with pending FDA GRASE determination", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens containing chemical UV filters with a pending FDA GRASE determination. No sunscreen active ingredient is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.broad_spectrum_test", "title": "'Broad Spectrum' claim requires documented Critical Wavelength test", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens making a \u201cBroad Spectrum\u201d claim. This label makes no sunscreen claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.water_resistance_label", "title": "Water resistance labeling: prohibited terms or missing required duration", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens making a water-resistance claim. This label makes no sunscreen claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.spf_skin_cancer_alert", "title": "Skin Cancer/Skin Aging Alert required for non-Broad-Spectrum or SPF < 15 sunscreens", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens with SPF below 15 or without Broad Spectrum protection. This label makes no SPF claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "MOCRA.adverse_event_contact", "title": "Domestic contact for adverse event reports present", "status": "error", "category": "federal", "evaluation_state": "fail" }, { "code": "mocra.responsible_person_non_us", "title": "Non-US distributor address: confirm MoCRA facility registration and US agent", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "mocra.professional_use_statement", "title": "Professional-use product carries the licensed-professionals statement (21 U.S.C. \u00a7 364e(c))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products the label restricts to professional or salon use (21 U.S.C. \u00a7 364e(c)). This label carries no such use restriction. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "status": "advisory", "category": "ingredient_restrictions", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "status": "advisory", "category": "ingredient_restrictions", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "PKG.toxics_in_packaging", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "status": "advisory", "category": "packaging", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "IH.restricted_preservative.phenoxyethanol", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "status": "advisory", "category": "ingredient_hazards", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "AMZ.ingredients_present", "title": "Full ingredient list required", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.net_quantity", "title": "Net quantity required on listing", "category": "retailer_amazon", "status": "error", "evaluation_state": "fail" }, { "code": "AMZ.no_drug_claims", "title": "No drug or therapeutic claims permitted", "category": "retailer_amazon", "status": "error", "evaluation_state": "fail" }, { "code": "AMZ.manufacturer_info", "title": "Manufacturer or responsible party required", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "category": "retailer_amazon", "status": "advisory", "evaluation_state": "advisory" }, { "code": "AMZ.no_formaldehyde", "title": "Formaldehyde and releasers restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.no_mercury", "title": "Mercury compounds restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.spf_otc_compliance", "title": "SPF products must comply with OTC drug monograph", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_triclosan", "title": "Triclosan restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_parabens", "title": "Propyl- and butyl-parabens restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_phthalates", "title": "Phthalates restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_npe", "title": "Nonylphenol and NP ethoxylates restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_pfas", "title": "Perfluorinated chemicals restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.marketplace_concentration_caps", "title": "Concentration cap exceeded (Amazon marketplace policy)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_misc", "title": "Other RSL substances restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_microplastics", "title": "Microplastics restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" } ], "scan_duration_ms": 761, "engine_version": "2.0.0", "rules_library_version": "v187.0b52d7", "ruleset_version": "2026.09.13", "git_sha": "1473b00", "rules_as_of": "2026-08-04", "regulatory_as_of": {}, "covered_regimes": [], "include_eu": false, "retailer_status": { "amazon": "caution" }, "retailer_not_covered_reasons": null, "entitled": true, "credit_balance": 0, "plan": "pro", "checks_performed_count": 204, "ih_findings_count": 1, "not_screened_count": 0, "claims_not_screened_count": 0, "extraction_unverified_not_screened_count": 0, "claims_error_count": 3, "claims_warning_count": 0, "manual_review_count": 37, "manual_review": [ { "kind": "unconfirmed_detection", "code": "AMZ.net_quantity", "title": "Net quantity required on listing", "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "citation_url": null }, { "kind": "unconfirmed_detection", "code": "AMZ.no_drug_claims", "title": "No drug or therapeutic claims permitted", "what_to_verify": "Amazon Beauty's published criteria are an optional badge program, not a condition of being sold there and not law. Verify against the retailer's current list before relying on this for a submission.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "what_to_verify": "California, Colorado, Connecticut, Illinois, Maine, Minnesota, New Hampshire, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington prohibit or restrict intentionally added PFAS in cosmetics; effective dates vary by state and each state's own finding gives its date. These are class-wide bans, so a label-text scan cannot certify the absence of all PFAS, many are undeclared or appear under trade names. No listed PFAS substance was detected on this label. Confirm with your formulator that no PFAS is intentionally added.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "what_to_verify": "Oregon, Vermont and Washington prohibit intentionally added ortho-phthalates in cosmetics; effective dates vary by state and each state's own finding gives its date. This is a class-wide ban and some ortho-phthalates are undisclosed under \"fragrance\", so a label-text scan cannot certify their absence. No phthalate was detected by name on this label. Confirm your formulation contains no intentionally added ortho-phthalates.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "PKG.toxics_in_packaging", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "what_to_verify": "Nineteen states have adopted the CONEG/TPCH Toxics in Packaging model law (count per the Toxics in Packaging Clearinghouse fact sheet, rev. Nov 2023). These limit lead, cadmium, mercury and hexavalent chromium in a package or packaging component to 100 parts per million by weight, stated as a combined total in every one of them except Iowa, whose text says only 'the concentration levels'. Five are verified against primary text: Florida (Fla. Stat. 403.7191(3)), Iowa (Iowa Code 455D.19(3)-(4)), Missouri (RSMo 260.822), Pennsylvania (Safe Packaging Act, Act of Dec. 7, 1994, P.L. 797, No. 112, sec. 301), Wisconsin (Wis. Stat. 100.285(2)). Georgia (O.C.G.A. 12-8-162) is included on a secondary reproduction only, not the official code. The 100 ppm tier is in force in all six. NOTE Wisconsin attaches NO PENALTY to its limit (Wis. Stat. 100.285(5)). Only PENNSYLVANIA prohibits INTENTIONAL introduction outright regardless of concentration; Georgia and Iowa carry that clause but gate it on also exceeding the agency-set level, and Florida, Wisconsin and Missouri have no such clause at all. SCOPE: this regulates the PACKAGE, expressly including inks, labels, coatings and closures, NOT the product formula. It therefore cannot be verified or violated by label text, and this scan does not check it.", "citation_url": "https://www.toxicsinpackaging.org" }, { "kind": "class_ban_advisory", "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "what_to_verify": "California Safe Cosmetics Program (CSCP): if your company's annual cosmetic sales exceed $1M AND this product contains any chemical on the CDPH Reportable Ingredients List (thousands of chemicals across 22 hazard lists, Prop 65, IARC, NTP, EPA, and EU classifications), you must report it to CDPH at cscpsubmit.cdph.ca.gov. This is a corporate reporting obligation, not an on-label requirement, and it cannot be determined from label text alone, it does not affect whether this label is compliant. Verify your reporting status with CDPH if the revenue threshold applies.", "citation_url": "https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=111792" }, { "kind": "class_ban_advisory", "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "what_to_verify": "New York caps 1,4-dioxane at 10 ppm in cosmetics and 1 ppm in personal care products (ECL Article 37 Title 1, \u00a7 37-0117(3)-(4); 6 NYCRR Subpart 352-1). It is a manufacturing impurity of ethoxylated ingredients (PEGs, -eth- surfactants, polysorbates), never a declared ingredient, so a label scan cannot verify the threshold. If your formula uses ethoxylated ingredients, obtain a 1,4-dioxane test report from your supplier, rinse-off personal care products face the tighter 1 ppm limit.", "citation_url": "https://dec.ny.gov/environmental-protection/pollution-prevention/household-personal-cosmetic-dioxane-limits" }, { "kind": "class_ban_advisory", "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "what_to_verify": "Minnesota caps lead at 90 ppm and cadmium at 75 ppm by total weight in cosmetics and personal care products (Minn. Stat. \u00a7 325E.3892). These are total-content limits, not declared-ingredient limits: colorant and pigment impurities can carry either metal below declaration level. No lead or cadmium compound is declared on this label, but a label scan cannot verify total content - obtain a heavy-metals certificate of analysis from your pigment and raw-material suppliers.", "citation_url": "https://www.revisor.mn.gov/statutes/cite/325E.3892" }, { "kind": "class_ban_advisory", "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "what_to_verify": "Vermont Act 131 (9 V.S.A. \u00a72494b, eff. Jan 1, 2026) bans 1,4-dioxane (>=10 ppm) and asbestos. These are typically undeclared contaminants (dioxane an impurity, asbestos a talc contaminant), so a label scan cannot certify their absence and the 10 ppm dioxane threshold is not verifiable from text. Confirm via supplier documentation / testing that 1,4-dioxane is below 10 ppm and no asbestos is present.", "citation_url": "https://legislature.vermont.gov/statutes/section/09/063/02494b" }, { "kind": "class_ban_advisory", "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "what_to_verify": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility.", "citation_url": "https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html" }, { "kind": "class_ban_advisory", "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "what_to_verify": "Oregon SB 546 formaldehyde-releasing-agent ban (eff. Jan 1, 2027): SB 546 \u00a74 bans this category generically (no statutory list). The scan checks a representative set of common formaldehyde donors; a no-match does not certify absence of every releasing agent. Before Jan 1, 2027 confirm your preservation system releases no formaldehyde (Oregon SB 546, \u00a74).", "citation_url": "https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/SB546/Enrolled" }, { "kind": "class_ban_advisory", "code": "IH.restricted_preservative.phenoxyethanol", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "what_to_verify": "Phenoxyethanol is on our watch list, but NO US federal or state rule we screen restricts it in cosmetics today, so this is not a violation and nothing on your label has to change because of it. Phenoxyethanol is flagged as a potential hazard (restricted preservative). Widely used cosmetic preservative. EU Annex V Entry 29: maximum 1.0%; no product-type restriction. Japan: 1.0% maximum in cosmetics under MHLW regulation. US: No 21 CFR prohibition. FDA issued a product-specific consumer warning in 2008 concerning Mommy's Bliss Nipple Cream containing phenoxyethanol + chlorphenesin, phenoxyethanol can depress the CNS and cause vomiting and diarrhea in infants via direct nipple-cream exposure. NOT a general FDA advisory on phenoxyethanol. Not Prop 65 listed. Flagged under some clean beauty retailer standards. Raise it with your formulator if the concern matters for your product or your retailer's own standards.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "what_to_verify": "Amazon's cosmetics listing requirements ask that units display identifying codes such as lot or serial numbers, and an expiration date for products with a shelf life under three years or otherwise a period-after-opening symbol such as '12M'. A lot code is usually a fill-line inkjet or laser mark and the PAO symbol is a pictogram, so neither can be verified from label text; this note appears on every Amazon check rather than reporting a false absence. Amazon's own cosmetics help page is behind a Seller Central sign-in.", "citation_url": null }, { "kind": "format_requirement", "code": "21 U.S.C. \u00a7 364e(c) (FD&C Act \u00a7 609)", "title": "Professional-use-only products must state they are for use only by licensed professionals", "what_to_verify": "If this product is distributed for use only by professionals, add a clear, prominent statement that it is to be used only by licensed professionals (cosmetology, nail care, barbering, or esthetics). A label scan cannot certify whether a product is professional-distribution-only, so confirm this applies to your product.", "citation_url": "https://uscode.house.gov/view.xhtml?req=(title:21%20section:364e%20edition:prelim)" }, { "kind": "format_requirement", "code": "21 CFR 701.13(e), (f), (i)", "title": "Net quantity placement and lettering size", "what_to_verify": "Put the net quantity on the front (principal display) panel, in the bottom 30% of that panel, parallel to the base. The bottom-30% placement requirement does not apply to panels of 5 square inches or less when the other requirements are met. Minimum letter height by panel size: 1/16\" (\u22645 sq in), 1/8\" (>5, 25), 3/16\" (>25, 100), 1/4\" (>100 up to 400), 1/2\" (>400). Add 1/16\" if lettering is blown, embossed, or molded. We can't measure panel size or lettering from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.13(f)", "title": "Clear space around the net quantity statement", "what_to_verify": "Separate the net quantity from other printed label information above and below by at least the height of its lettering. Leave at least twice the width of its letter N to the left and right. Confirm this on the print artwork; the current PDF checks do not measure this clearance.", "citation_url": "https://www.ecfr.gov/current/title-21/section-701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.11", "title": "Statement of identity prominence and placement", "what_to_verify": "Show what the product is (common name, descriptive name, or an illustration) on the front panel as one of its main features, in bold type, sized in proportion to the most prominent text on that panel. We can't verify size or panel position from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.11" }, { "kind": "format_requirement", "code": "21 CFR 701.3(a), (f)", "title": "Ingredients in descending order of predominance", "what_to_verify": "List ingredients from most to least by amount. Exception: ingredients at 1% or less may appear in any order after those above 1%, and color additives may appear in any order at the end. We can't see your formula's concentrations from the label, so we can't verify the order, confirm it matches your formulation.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3", "title": "Ingredient lettering size / small-package options", "what_to_verify": "Ingredient lettering must meet the minimum height for your package size. Very small packages may place the ingredient list on a tag, tape, or card firmly affixed to the package, or on accompanying display material. We can't measure this from text, confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3, 701.12, 701.13(e)", "title": "Correct panel placement (front panel vs. information panel)", "what_to_verify": "Net quantity goes on the front (principal display) panel; the ingredient list and the manufacturer/distributor name and address may go on an information panel. We check that this information is present in your text but can't tell which physical panel it's on, confirm panel placement on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12" }, { "kind": "format_requirement", "code": "21 CFR 701.2", "title": "Conspicuousness, contrast, and English", "what_to_verify": "All required statements must be in English and easy to find and read under normal shopping conditions, adequate type size, good contrast, not crowded. If any required statement also appears in another language, all required statements must appear in that language too. We can't assess size, contrast, or prominence from text; confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.2" }, { "kind": "format_requirement", "code": "21 CFR 740.10", "title": "Safety-substantiation warning (if applicable)", "what_to_verify": "If your product's safety has not been adequately substantiated, the front panel must bear, word for word: \"Warning\u2014The safety of this product has not been determined.\" We can't tell from the label whether your safety data is on file, confirm whether this applies.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.10" }, { "kind": "format_requirement", "code": "21 CFR 740.19", "title": "Tanning / self-tanner warning (if applicable)", "what_to_verify": "If your product is a suntanning preparation that does not contain a sunscreen, its labeling must display, word for word: \"Warning-This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.\" 21 CFR 740.19 defines \"suntanning preparations\" to include topical products that give a cosmetic effect on the skin while tanning under UV radiation and products that give the appearance of a tan with an approved colour additive such as dihydroxyacetone. We check this automatically when the label names the product as a tanning or self-tanning preparation, or declares dihydroxyacetone. If your product is one and uses wording we did not recognise, confirm this yourself.", "citation_url": "https://www.ecfr.gov/current/title-21/section-740.19" }, { "kind": "format_requirement", "code": "21 CFR 740.11", "title": "Aerosol / pressurized-container warnings (if applicable)", "what_to_verify": "If your product is in a pressurized (aerosol) container, it must bear, word for word: \"Warning\u2014Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 \u00b0F. Keep out of reach of children.\" (Glass: use \"break\" for \"puncture\"; non-spray: omit \"Avoid spraying in eyes\"; children's: add \"except under adult supervision.\") If it uses a halocarbon or hydrocarbon propellant, also: \"Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.\"", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.11" }, { "kind": "format_requirement", "code": "21 CFR 740.2", "title": "Warning-statement conspicuousness (type size, bold, contrast)", "what_to_verify": "Every warning statement must appear prominently and conspicuously compared to other words and designs, in bold type on contrasting background, likely to be read under customary conditions of purchase and use - and never in letters or numbers under 1/16 inch in height (unless FDA has granted a small-package exemption by regulation). We can verify a warning's TEXT is present but not its size, weight, or contrast; confirm these on your packaging artwork.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.2" }, { "kind": "format_requirement", "code": "21 CFR 700.25", "title": "Tamper-resistant packaging for cosmetic liquid oral hygiene and vaginal products (if applicable)", "what_to_verify": "If this product is a cosmetic liquid oral hygiene product or a cosmetic vaginal product, and it is accessible to the public while held for sale, it must be packaged in a tamper-resistant retail package. Except for aerosol products, the retail package must also bear a statement, prominently placed, that alerts consumers to the specific tamper-resistant feature. (An oral-hygiene product marketed with a therapeutic claim is an OTC drug, not a cosmetic, and is covered by 21 CFR 211.132 instead.) A label-text scan cannot verify packaging, so confirm whether this applies to your product.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.25" }, { "kind": "format_requirement", "code": "21 CFR 700.27", "title": "No prohibited cattle (BSE) materials in the formulation (if applicable)", "what_to_verify": "No cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials: specified risk materials, the small intestine of all cattle (unless the distal ileum has been removed by the procedure the regulation specifies), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef. The definition expressly EXCLUDES tallow containing no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, so most common bovine-derived cosmetic ingredients fall outside the ban. If your formula uses any other bovine-derived ingredient, confirm its sourcing with your supplier. A label scan cannot verify ingredient sourcing.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.27" }, { "kind": "format_requirement", "code": "21 CFR 701.3(q); 21 CFR 701.3(i)-(k)", "title": "Ingredient declaration on multiunit and multicomponent packages (if applicable)", "what_to_verify": "21 CFR 701.3(q): the inside containers of a multiunit or multicomponent package need no ingredient declaration when the outer package bears one that meets this section and the inner units are not sold separately. Separately, 701.3(i)-(k) let a package with less than 12 square inches of label surface carry its declaration on a firmly affixed tag, tape or card, or in leaflet labeling on a display unit or chart; such a display unit must carry the words \"Federal law requires ingredient lists to be displayed here\" in letters not less than 3/16 inch high, conspicuous when no lists remain. Not applicable if the individual units' ingredient declarations are already visible through or on the display package. A label-text scan of a single product panel cannot tell whether this product is sold as part of such a display package.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(n)", "title": "\"New ingredient list\" overlabeling notice on formulation changes (if applicable)", "what_to_verify": "21 CFR 701.3(n) is a permission, not a general overlabel duty: when a shortage of a cosmetic ingredient forces a formulation change, packages already printed with the old declaration may still be used if the revised declaration appears either on a firmly affixed tag, tape, card or sticker bearing the conspicuous words \"new ingredient list\" in letters not less than 1/16 inch high, or on labeling inside an unsealed package whose outside bears \"new ingredient list inside\". Not applicable to a label being printed for the first time. A label-text scan cannot tell whether this PDF is such an overlabel.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(1)", "title": "\"May contain\" color additive declaration for batch color-matching (if applicable)", "what_to_verify": "If a color additive is added to only SOME batches of this product for the purpose of color matching, you may declare it using the phrase \"may contain\" (e.g. \"May Contain: Red 33\") instead of listing it as though every batch contains it. This is an OPTIONAL labeling accommodation - a label that lists every color additive unconditionally is also compliant. A label-text scan cannot tell whether a given batch actually varies this way; confirm with your formulator which additives are batch-variable before using this declaration style.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(h)", "title": "Composite color-additive list for an assortment sold in one package (if applicable)", "what_to_verify": "If this product ships as part of an assortment of cosmetics sold together in the same package, you may declare the COLOR ADDITIVES of the whole assortment in a single composite list - instead of a separate color-additive declaration for each product - as long as the listing is not misleading and makes clear it covers every product in the package. This applies to color additives only; the rest of the ingredient declaration follows the ordinary rules. A label-text scan of one product panel cannot tell whether it ships packaged together with others.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(o)", "title": "Cumulative ingredient list for an assortment of similar products (if applicable)", "what_to_verify": "If this product is sold as part of an assortment of products similar in composition and intended for the same use (FDA's example is an eyeshadow palette), you may declare the ingredients common to all of them in a single cumulative list, together with a statement identifying which products contain the other, non-common ingredients - or, if the package's labelable surface is under 12 square inches, in one combined list with no separate non-common statement required. A label-text scan of one product panel cannot tell whether it ships as part of such an assortment.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(2), (o)(3)-(4)", "title": "Shared label declaration for a branded shade line (if applicable)", "what_to_verify": "If this product is one item in a branded shade line sold under a common trade name with no other brand appearing on any item (FDA's examples: one lipstick in a line of lipsticks, or one compact in a line of compacts), the line may share a single label declaring the ingredients common to all shades, plus a statement identifying the other, shade-specific ingredients and which product(s) contain them; shade-specific color additives may use the \"may contain\" declaration under 701.3(g)(2). A label-text scan of one shade's panel cannot tell whether it is part of such a line.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(r)", "title": "Direct-mail alternative ingredient declaration (if applicable)", "what_to_verify": "If this product is sold to consumers by direct mail, the ingredient declaration may appear (letters not less than 1/16 inch high) in the accompanying mailing, sales catalog, or brochure instead of on the package, PROVIDED the mailed package itself carries a notice - visible on opening, letters not less than 3/16 inch high - that states where the declaration is located, promises a copy will be mailed promptly on request, and gives the mail-order distributor's name and place of business; the distributor must then actually fulfill that promise when asked. A label-text scan of the package panel cannot tell whether this product is sold by direct mail or whether the required catalog/brochure declaration exists.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(i)-(k)", "title": "Off-package leaflet ingredient declaration for small/compartmented display units (if applicable)", "what_to_verify": "If this product's package has under 12 square inches of labelable surface (and is not enclosed in an outer carton), the ingredient declaration may instead appear (letters not less than 1/16 inch high) on an accompanying leaflet attached to a compartmented display tray or rack - or, for a shade-matched assortment, attached to a display chart bearing shade samples - rather than on each unit. Strict conditions apply: the leaflet must be visible per specific placement rules (fully readable from the front, or accompanied by a 3/16-inch notice if partially visible or on a side); all copies used with one display must be identical; the unit must ship together with its labeling; the display must show \"Federal law requires ingredient lists to be displayed here\" (3/16 inch minimum) whenever no declaration is currently attached; a formulation change requires the leaflet to be dated and to distinguish old vs. new formula; sufficient copies must be provided for every purchaser; and the firm named on the product must mail a copy to anyone who requests one. A label-text scan of one product's panel cannot tell whether it is sold this way or whether the display unit meets these conditions.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "15 U.S.C. \u00a7 1278a; 16 CFR 1303.2; 16 CFR 1307.2-.3", "title": "CPSIA lead and phthalate limits for children's cosmetics/packaging (if applicable)", "what_to_verify": "If this product, its packaging, or an accessory (e.g. an applicator) is a children's product as defined by the CPSIA, or has any paint or similar surface coating, two federal chemical limits apply: (1) total lead content in any accessible substrate material may not exceed 100 ppm (15 U.S.C. \u00a7 1278a), and lead in paint or similar surface coatings may not exceed 0.009% / 90 ppm (16 CFR 1303.2); (2) a children's toy or child care article may not contain more than 0.1% of any of eight prohibited phthalates - DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP (16 CFR 1307.2-.3) - applying equally to toys and child care articles, no mouth-contact or age distinction. DIDP and DnOP, part of the ORIGINAL 2008 interim ban, are NOT on the current permanent list and are not restricted by this rule today. These are formula/material composition facts a label-text scan cannot see - confirm testing with your supplier if this product is marketed to or usable by children.", "citation_url": "https://www.law.cornell.edu/cfr/text/16/1307.3" }, { "kind": "format_requirement", "code": "19 U.S.C. \u00a7 1304(a)", "title": "Country-of-origin marking for imported product (if applicable)", "what_to_verify": "If this product is of foreign origin, the ARTICLE itself - not merely the shipping carton - must be marked in a conspicuous place, as legibly, indelibly and permanently as the nature of the article will permit, with the English name of the country of origin, for example \"Made in France\". We raise a specific finding automatically only when the label carries a non-US address and we find no origin mark on it. Whether the product is in fact imported, and whether the physical marking is conspicuous, indelible and permanent enough, are facts about the finished package that a label-text scan cannot determine, so confirm both with your manufacturer. If the article is made in the United States, this statute requires no marking.", "citation_url": "https://www.law.cornell.edu/uscode/text/19/1304" } ], "analysis_quality": { "input_source": "pasted", "photo_count": null, "ocr_confidence": null, "claims_confidence": null, "extraction_unverified": false, "ingredient_declaration_readable": true, "claims_screening_incomplete": false, "not_detected_codes": [], "limits": [], "can_certify": true } }, "after": { "retailer_programs_violated": 0, "status": "pass", "verdict": "pass_with_caveats", "issue_counts": { "issue_blocking": 0, "issue_caution": 0, "issue_total": 0, "rule_total": 0 }, "verdict_tier": "green_advisory", "verdict_markers": [ "advisories" ], "violations": [], "checked_regulations": [ "21 CFR 740.1, Discontinue use if irritation warning", "FD&C Act 505(a) / 21 U.S.C. 355(a) and 503(b)(1)(A) / 21 U.S.C. 353(b)(1)(A); applied in FDA Warning Letter to Lifetech Resources LLC, April 18 2011, Prostaglandin analog in a lash or brow product: unapproved prescription drug", "21 U.S.C. \u00a7 364e(a) / MoCRA, domestic contact for adverse event reports", "21 CFR 701.2, Required information appears in English", "Microbead-Free Waters Act of 2015, 21 U.S.C. 331(ddd), Plastic microbeads prohibited in rinse-off cosmetics", "FD&C Act \u00a7 505(a) / CARES Act \u00a7 505G(a)(4), Not-GRASE active ingredient check", "21 CFR Parts 73 and 74, Color additive approval", "21 CFR 700.13, FDA restricted ingredient: Mercury compounds", "21 CFR 701.3, Ingredient declaration present", "21 CFR 740.1, External use only warning", "FD&C Act \u00a7 601 / 21 U.S.C. \u00a7 361, Coal-tar hair dye caution", "FPLA 15 U.S.C. \u00a7 1453(a)(2), Net quantity dual metric/US customary format", "21 CFR 700.23, FDA prohibited ingredient: Chlorofluorocarbon propellants", "40 CFR 82.106, HCFC ozone-depletion warning", "Marine Mammal Protection Act, 16 U.S.C. 1361 et seq.; Endangered Species Act, 16 U.S.C. 1538(a)(1)(E)-(F); Whaling Convention Act, 16 U.S.C. 916c(a)(2); Cal. Penal Code 653o(a), Cetacean-derived ingredient: prohibited from US commerce", "21 CFR 701.12, Complete place of business required", "21 CFR 310.545(a)(1) and (d)(1); 21 CFR 333.310(d) (acne monograph strength), Salicylic acid above 2% in an acne product: unapproved new drug", "21 CFR 700.16, FDA restricted ingredient: Zirconium compounds in aerosol cosmetics", "Panel placement, PDP / information panel structure", "21 CFR 701.11, Identity statement present", "21 CFR 701.13, Net quantity of contents present", "21 CFR 700.15, FDA prohibited ingredient: Halogenated salicylanilides", "21 CFR 700.11, FDA prohibited ingredient: Bithionol", "21 CFR 740.1 (general warning standard; discretionary best practice, not a specific eye-contact requirement), Eye-contact warning (best practice)", "84 FR 6204 / \u00a7 505G, Category II sunscreen active (not-GRASE, not legally marketable)", "21 CFR 740.1 (cosmetic warning statements; warning required whenever necessary or appropriate to prevent a health hazard), Flammability warning if applicable", "21 CFR 701.3(a), Ingredient declaration format", "21 CFR 700.14, FDA prohibited ingredient: Vinyl chloride", "21 CFR 701.2(b), Foreign-language label consistency", "21 CFR 701.12, Manufacturer or distributor present", "21 CFR 700.18, FDA prohibited ingredient: Chloroform", "84 FR 6204 / \u00a7 505G(b), Category III sunscreen active (GRASE determination pending)", "FD&C Act 505G / 21 U.S.C. 355h; OTC Monograph M017 (External Analgesic Drug Products for OTC Human Use); 21 CFR 201.66, Anesthetic active declared without a Drug Facts panel", "21 CFR 740.17, Foaming detergent bath caution", "21 CFR 701.13(d)/(j)(1)/(n)/(q), Net quantity declaration form", "21 CFR 740.1 (general cosmetic warning authority); 21 CFR 740.11 for self-pressurized containers, Eye-contact warning", "21 CFR 700.19, FDA prohibited ingredient: Methylene chloride", "21 CFR 700.25, Tamper-resistant packaging statement", "21 CFR 740.12, Feminine deodorant spray caution", "FD&C Act 601(e) / 21 U.S.C. 361(e); 21 CFR Parts 73, 74 and 82 (colour additive listings), FDA prohibited: kohl, kajal, al-kahal or surma", "21 CFR 740.1 (general standard); the phrase is mandated word-for-word by 740.11(a)(1) (self-pressurized/aerosol cosmetics) and 740.17(b) (foaming detergent bath products), and by 21 CFR 201.66(c)(5)(x) for OTC drug labels, Children safety warning (best practice)", "21 CFR 250.250, FDA restricted ingredient: Hexachlorophene" ], "violated_regulations": [], "pass_reasons": [ "Domestic contact for adverse event reports present (21 U.S.C. \u00a7 364e(a)).", "Identity statement present: The PDP must clearly identify the product (e.g. 'Face Serum', 'Moisturizing Lotion'). (Evidence: \"Serum\")", "Net quantity of contents present: PDP must include net quantity by weight, measure, or count. (Evidence: \"Net Contents 1 fl oz\")", "Manufacturer or distributor present: Label must include name and place of business of manufacturer, packer, or distributor. (Evidence: \"Manufactured by Example Beauty, 100 Example St, Austin, TX 78701 Questions or a...\")", "Eye-contact warning (best practice): eye-contact warning present", "Children safety warning (best practice): Include 'Keep out of reach of children' for potentially irritating products. (Evidence: \"Keep out of reach of children\")", "Required information appears in English: All required label information must appear in English per 21 CFR \u00a7 701.2. If a foreign language also appears anywhere on the label, all required statements must also appear in that foreign language. (Evidence: \"Net\")", "Flammability warning if applicable: No flammable ingredients detected", "Net quantity declared in both metric and US customary units", "21 CFR 701.13(j)(1), Net quantity restatement not required or present", "21 CFR 701.13(d), Net quantity carries no non-permitted fraction", "21 CFR 701.13(n), Net quantity uses only permitted abbreviations", "21 CFR 701.13(q), No exaggerating qualifier beside the net quantity", "Manufacturer place of business appears complete", "Ingredient declaration present: standard ingredient heading detected.", "Ingredient list appears comma-separated", "Prostaglandin analog in a lash or brow product: unapproved prescription drug: not detected in the ingredient declaration", "Salicylic acid above 2% in an acne product: unapproved new drug: not detected in the ingredient declaration", "Anesthetic active declared without a Drug Facts panel: not detected in the ingredient declaration -- benzocaine and lidocaine are the two anesthetic actives this check covers. FDA's monograph M017 lists others (pramoxine, dibucaine, tetracaine, dyclonine, phenol) that this check does not look for -- confirm those by hand.", "FDA prohibited: kohl, kajal, al-kahal or surma: not detected in the ingredient declaration", "Cetacean-derived ingredient: prohibited from US commerce: not detected in the ingredient declaration", "Plastic microbeads prohibited in rinse-off cosmetics: plastic microbeads and plastic polymers not detected in the ingredient declaration", "FDA prohibited ingredient: Bithionol: not detected in the ingredient declaration", "FDA prohibited ingredient: Chloroform: not detected in the ingredient declaration", "FDA prohibited ingredient: Halogenated salicylanilides: not detected in the ingredient declaration", "FDA prohibited ingredient: Methylene chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Vinyl chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Chlorofluorocarbon propellants: not detected in the ingredient declaration", "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics: not detected in the ingredient declaration", "FDA restricted ingredient: Hexachlorophene: not detected in the ingredient declaration", "FDA restricted ingredient: Mercury compounds: not detected in the ingredient declaration", "No not-GRASE active (hydroquinone) detected on label", "No 'Active Ingredient:' header, FD&C \u00a7 505(a) and Category III checks not applicable", "California Prop 65 warning may be required: No prohibited content detected.", "Prop 65 warning does not match the safe-harbor format: No prohibited content detected.", "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762): No prohibited content detected.", "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643): No prohibited content detected.", "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion: No prohibited content detected.", "Banned for sale in California (2027): styrene / vinyl acetate monomer: No prohibited content detected.", "Musk ketone capped in California (2027): concentration limits by product type: No prohibited content detected.", "Banned for sale in California (2027): boron compounds (boric acid / borates): No prohibited content detected.", "Banned for sale in California (2027): Laurus nobilis seed oil: No prohibited content detected.", "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products: No prohibited content detected.", "Louisiana mercury limit in cosmetics (10 ppm): No prohibited content detected.", "New York mercury prohibition in cosmetics: No prohibited content detected.", "New York hair-relaxer carcinogen warning (takes effect May 21, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Minnesota mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Minnesota formaldehyde ban in children's products (under age 8): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Washington Toxic-Free Cosmetics Act: No prohibited content detected.", "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027): No prohibited content detected.", "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Maryland PFAS prohibition in cosmetics (HB 643): No prohibited content detected.", "Banned for sale in Vermont: Act 131 named substances: No prohibited content detected.", "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene: No prohibited content detected.", "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited: No prohibited content detected.", "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027): No prohibited content detected.", "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028): No prohibited content detected.", "Illinois mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Arkansas hair-relaxer carcinogen warning (in force since 2025): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result.", "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122): No prohibited content detected.", "Virginia PFAS prohibition in cosmetics (HB 122): No prohibited content detected.", "Color additives: no FD&C/D&C colour name was declared on this label", "21 CFR 740.1, 'For external use only' warning present", "21 CFR 740.1, Discontinue use if irritation warning present", "21 CFR 740.11, Eye contact warning present" ], "violations_by_category": {}, "pass_by_category": { "manufacturer": [ "Domestic contact for adverse event reports present (21 U.S.C. \u00a7 364e(a))." ], "pdp": [ "Identity statement present: The PDP must clearly identify the product (e.g. 'Face Serum', 'Moisturizing Lotion'). (Evidence: \"Serum\")", "Net quantity of contents present: PDP must include net quantity by weight, measure, or count. (Evidence: \"Net Contents 1 fl oz\")", "Manufacturer or distributor present: Label must include name and place of business of manufacturer, packer, or distributor. (Evidence: \"Manufactured by Example Beauty, 100 Example St, Austin, TX 78701 Questions or a...\")", "Required information appears in English: All required label information must appear in English per 21 CFR \u00a7 701.2. If a foreign language also appears anywhere on the label, all required statements must also appear in that foreign language. (Evidence: \"Net\")" ], "warnings": [ "Eye-contact warning (best practice): eye-contact warning present", "Children safety warning (best practice): Include 'Keep out of reach of children' for potentially irritating products. (Evidence: \"Keep out of reach of children\")", "Flammability warning if applicable: No flammable ingredients detected", "21 CFR 740.1, 'For external use only' warning present", "21 CFR 740.1, Discontinue use if irritation warning present", "21 CFR 740.11, Eye contact warning present" ], "federal": [ "Net quantity declared in both metric and US customary units", "21 CFR 701.13(j)(1), Net quantity restatement not required or present", "21 CFR 701.13(d), Net quantity carries no non-permitted fraction", "21 CFR 701.13(n), Net quantity uses only permitted abbreviations", "21 CFR 701.13(q), No exaggerating qualifier beside the net quantity", "Manufacturer place of business appears complete", "Ingredient declaration present: standard ingredient heading detected.", "Ingredient list appears comma-separated", "Prostaglandin analog in a lash or brow product: unapproved prescription drug: not detected in the ingredient declaration", "Salicylic acid above 2% in an acne product: unapproved new drug: not detected in the ingredient declaration", "Anesthetic active declared without a Drug Facts panel: not detected in the ingredient declaration -- benzocaine and lidocaine are the two anesthetic actives this check covers. FDA's monograph M017 lists others (pramoxine, dibucaine, tetracaine, dyclonine, phenol) that this check does not look for -- confirm those by hand.", "FDA prohibited: kohl, kajal, al-kahal or surma: not detected in the ingredient declaration", "Cetacean-derived ingredient: prohibited from US commerce: not detected in the ingredient declaration", "Plastic microbeads prohibited in rinse-off cosmetics: plastic microbeads and plastic polymers not detected in the ingredient declaration", "FDA prohibited ingredient: Bithionol: not detected in the ingredient declaration", "FDA prohibited ingredient: Chloroform: not detected in the ingredient declaration", "FDA prohibited ingredient: Halogenated salicylanilides: not detected in the ingredient declaration", "FDA prohibited ingredient: Methylene chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Vinyl chloride: not detected in the ingredient declaration", "FDA prohibited ingredient: Chlorofluorocarbon propellants: not detected in the ingredient declaration", "FD&C \u00a7 505(a), no not-GRASE active detected", "FD&C \u00a7 505(a) / 84 FR 6204, No active ingredient header detected" ], "ingredient_restrictions": [ "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics: not detected in the ingredient declaration", "FDA restricted ingredient: Hexachlorophene: not detected in the ingredient declaration", "FDA restricted ingredient: Mercury compounds: not detected in the ingredient declaration" ], "state_CA": [ "California Prop 65 warning may be required: No prohibited content detected.", "Prop 65 warning does not match the safe-harbor format: No prohibited content detected.", "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762): No prohibited content detected.", "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion: No prohibited content detected.", "Banned for sale in California (2027): styrene / vinyl acetate monomer: No prohibited content detected.", "Musk ketone capped in California (2027): concentration limits by product type: No prohibited content detected.", "Banned for sale in California (2027): boron compounds (boric acid / borates): No prohibited content detected.", "Banned for sale in California (2027): Laurus nobilis seed oil: No prohibited content detected." ], "state_MD": [ "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643): No prohibited content detected.", "Maryland PFAS prohibition in cosmetics (HB 643): No prohibited content detected." ], "state_WI": [ "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products: No prohibited content detected." ], "state_LA": [ "Louisiana mercury limit in cosmetics (10 ppm): No prohibited content detected." ], "state_NY": [ "New York mercury prohibition in cosmetics: No prohibited content detected.", "New York hair-relaxer carcinogen warning (takes effect May 21, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_MN": [ "Minnesota mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected.", "Minnesota formaldehyde ban in children's products (under age 8): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_WA": [ "Washington Toxic-Free Cosmetics Act: No prohibited content detected.", "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027): No prohibited content detected.", "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_CO": [ "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_VT": [ "Banned for sale in Vermont: Act 131 named substances: No prohibited content detected.", "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene: No prohibited content detected." ], "state_HI": [ "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited: No prohibited content detected." ], "state_OR": [ "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027): No prohibited content detected." ], "state_IL": [ "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028): No prohibited content detected.", "Illinois mercury prohibition in cosmetics, toiletries and fragrances: No prohibited content detected." ], "state_AR": [ "Arkansas hair-relaxer carcinogen warning (in force since 2025): not applicable to this product. This restriction attaches only to a specific product category, and nothing on this label identifies it as one. If your product IS in that category, name it in the identity statement and re-scan - that is what this check reads. This does not affect your compliance result." ], "state_VA": [ "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122): No prohibited content detected.", "Virginia PFAS prohibition in cosmetics (HB 122): No prohibited content detected." ], "color_additives": [ "Color additives: no FD&C/D&C colour name was declared on this label" ] }, "advisories": [ { "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "message": "California, Colorado, Connecticut, Illinois, Maine, Minnesota, New Hampshire, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington prohibit or restrict intentionally added PFAS in cosmetics; effective dates vary by state and each state's own finding gives its date. These are class-wide bans, so a label-text scan cannot certify the absence of all PFAS, many are undeclared or appear under trade names. No listed PFAS substance was detected on this label. Confirm with your formulator that no PFAS is intentionally added.", "citations": "CA California AB 2771 \u00b7 CO C.R.S. \u00a7\u00a7 25-15-601 to -604 \u00b7 CT Conn. Gen. Stat. 22a-903c \u00b7 IL 410 ILCS 612 \u00b7 ME 38 M.R.S. \u00a71614 \u00b7 MN Minn. Stat. \u00a7 116.943 \u00b7 NH N.H. Rev. Stat. Ann. \u00a7 149-M:64, IV \u00b7 NJ N.J.S.A. 56:3-53 et seq. \u00b7 NM N.M. Per- and Poly-Fluoroalkyl Substances Pr \u00b7 OR Oregon SB 546 \u00b7 RI R.I. Gen. Laws 23-18.18-4 \u00b7 VT 9 V.S.A. \u00a7 2494b \u00b7 WA Chapter 70A.560 RCW", "scope": "formulation" }, { "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "message": "Oregon, Vermont and Washington prohibit intentionally added ortho-phthalates in cosmetics; effective dates vary by state and each state's own finding gives its date. This is a class-wide ban and some ortho-phthalates are undisclosed under \"fragrance\", so a label-text scan cannot certify their absence. No phthalate was detected by name on this label. Confirm your formulation contains no intentionally added ortho-phthalates.", "citations": "OR Oregon SB 546 \u00b7 VT 9 V.S.A. \u00a72494b \u00b7 WA RCW 70A.560.020", "scope": "formulation" }, { "code": "PKG.toxics_in_packaging", "citation_url": "https://www.toxicsinpackaging.org", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "scope": "formulation", "message": "Nineteen states have adopted the CONEG/TPCH Toxics in Packaging model law (count per the Toxics in Packaging Clearinghouse fact sheet, rev. Nov 2023). These limit lead, cadmium, mercury and hexavalent chromium in a package or packaging component to 100 parts per million by weight, stated as a combined total in every one of them except Iowa, whose text says only 'the concentration levels'. Five are verified against primary text: Florida (Fla. Stat. 403.7191(3)), Iowa (Iowa Code 455D.19(3)-(4)), Missouri (RSMo 260.822), Pennsylvania (Safe Packaging Act, Act of Dec. 7, 1994, P.L. 797, No. 112, sec. 301), Wisconsin (Wis. Stat. 100.285(2)). Georgia (O.C.G.A. 12-8-162) is included on a secondary reproduction only, not the official code. The 100 ppm tier is in force in all six. NOTE Wisconsin attaches NO PENALTY to its limit (Wis. Stat. 100.285(5)). Only PENNSYLVANIA prohibits INTENTIONAL introduction outright regardless of concentration; Georgia and Iowa carry that clause but gate it on also exceeding the agency-set level, and Florida, Wisconsin and Missouri have no such clause at all. SCOPE: this regulates the PACKAGE, expressly including inks, labels, coatings and closures, NOT the product formula. It therefore cannot be verified or violated by label text, and this scan does not check it.", "suggested_fix": "Request a Certificate of Compliance from your packaging and label printers stating that the carton, label, inks, coatings and closure meet the CONEG/TPCH 100 ppm limit for total lead, cadmium, mercury and hexavalent chromium. That document is per component, not a label change. Note that in Florida, Georgia, Missouri and Pennsylvania the prohibition also reaches whoever offers the PRODUCT for sale, so as the brand owner you are a regulated party yourself, not merely a purchaser relying on your printer's paperwork." }, { "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "citation_url": "https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=111792", "scope": "formulation", "message": "California Safe Cosmetics Program (CSCP): if your company's annual cosmetic sales exceed $1M AND this product contains any chemical on the CDPH Reportable Ingredients List (thousands of chemicals across 22 hazard lists, Prop 65, IARC, NTP, EPA, and EU classifications), you must report it to CDPH at cscpsubmit.cdph.ca.gov. This is a corporate reporting obligation, not an on-label requirement, and it cannot be determined from label text alone, it does not affect whether this label is compliant. Verify your reporting status with CDPH if the revenue threshold applies." }, { "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "citation_url": "https://dec.ny.gov/environmental-protection/pollution-prevention/household-personal-cosmetic-dioxane-limits", "scope": "formulation", "message": "New York caps 1,4-dioxane at 10 ppm in cosmetics and 1 ppm in personal care products (ECL Article 37 Title 1, \u00a7 37-0117(3)-(4); 6 NYCRR Subpart 352-1). It is a manufacturing impurity of ethoxylated ingredients (PEGs, -eth- surfactants, polysorbates), never a declared ingredient, so a label scan cannot verify the threshold. If your formula uses ethoxylated ingredients, obtain a 1,4-dioxane test report from your supplier, rinse-off personal care products face the tighter 1 ppm limit." }, { "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "citation_url": "https://www.revisor.mn.gov/statutes/cite/325E.3892", "scope": "formulation", "message": "Minnesota caps lead at 90 ppm and cadmium at 75 ppm by total weight in cosmetics and personal care products (Minn. Stat. \u00a7 325E.3892). These are total-content limits, not declared-ingredient limits: colorant and pigment impurities can carry either metal below declaration level. No lead or cadmium compound is declared on this label, but a label scan cannot verify total content - obtain a heavy-metals certificate of analysis from your pigment and raw-material suppliers." }, { "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "citation_url": "https://legislature.vermont.gov/statutes/section/09/063/02494b", "scope": "formulation", "message": "Vermont Act 131 (9 V.S.A. \u00a72494b, eff. Jan 1, 2026) bans 1,4-dioxane (>=10 ppm) and asbestos. These are typically undeclared contaminants (dioxane an impurity, asbestos a talc contaminant), so a label scan cannot certify their absence and the 10 ppm dioxane threshold is not verifiable from text. Confirm via supplier documentation / testing that 1,4-dioxane is below 10 ppm and no asbestos is present." }, { "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "citation_url": "https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html", "scope": "formulation", "message": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility." }, { "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "citation_url": "https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/SB546/Enrolled", "scope": "formulation", "message": "Oregon SB 546 formaldehyde-releasing-agent ban (eff. Jan 1, 2027): SB 546 \u00a74 bans this category generically (no statutory list). The scan checks a representative set of common formaldehyde donors; a no-match does not certify absence of every releasing agent. Before Jan 1, 2027 confirm your preservation system releases no formaldehyde (Oregon SB 546, \u00a74)." }, { "code": "IH.restricted_preservative.phenoxyethanol", "scope": "formulation", "detected": "yes", "severity": "warning", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "message": "Phenoxyethanol is on our watch list, but NO US federal or state rule we screen restricts it in cosmetics today, so this is not a violation and nothing on your label has to change because of it. Phenoxyethanol is flagged as a potential hazard (restricted preservative). Widely used cosmetic preservative. EU Annex V Entry 29: maximum 1.0%; no product-type restriction. Japan: 1.0% maximum in cosmetics under MHLW regulation. US: No 21 CFR prohibition. FDA issued a product-specific consumer warning in 2008 concerning Mommy's Bliss Nipple Cream containing phenoxyethanol + chlorphenesin, phenoxyethanol can depress the CNS and cause vomiting and diarrhea in infants via direct nipple-cream exposure. NOT a general FDA advisory on phenoxyethanol. Not Prop 65 listed. Flagged under some clean beauty retailer standards. Raise it with your formulator if the concern matters for your product or your retailer's own standards.", "suggested_fix": "No action is required to comply with US law. Check with your formulator whether to keep the ingredient, and confirm your retailer's own standards if you sell into a program that screens it.", "source_url": "" }, { "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "message": "Amazon's cosmetics listing requirements ask that units display identifying codes such as lot or serial numbers, and an expiration date for products with a shelf life under three years or otherwise a period-after-opening symbol such as '12M'. A lot code is usually a fill-line inkjet or laser mark and the PAO symbol is a pictogram, so neither can be verified from label text; this note appears on every Amazon check rather than reporting a false absence. Amazon's own cosmetics help page is behind a Seller Central sign-in.", "suggested_fix": "Confirm with your filler that each unit carries a lot or serial code, and that products with a shelf life under three years carry an expiration date (otherwise a PAO symbol such as 12M).", "detected": false, "evidence": null, "source_url": "https://sellercentral.amazon.com/help/hub/reference/external/200164470", "programme": null, "retailer": "amazon", "scope": "formulation" } ], "claims_risks": [], "format_guidance": [ { "requirement": "Professional-use-only products must state they are for use only by licensed professionals", "citation": "21 U.S.C. \u00a7 364e(c) (FD&C Act \u00a7 609)", "what_user_must_do": "If this product is distributed for use only by professionals, add a clear, prominent statement that it is to be used only by licensed professionals (cosmetology, nail care, barbering, or esthetics). A label scan cannot certify whether a product is professional-distribution-only, so confirm this applies to your product.", "can_engine_verify": false, "source_url": "https://uscode.house.gov/view.xhtml?req=(title:21%20section:364e%20edition:prelim)" }, { "requirement": "Net quantity placement and lettering size", "citation": "21 CFR 701.13(e), (f), (i)", "what_user_must_do": "Put the net quantity on the front (principal display) panel, in the bottom 30% of that panel, parallel to the base. The bottom-30% placement requirement does not apply to panels of 5 square inches or less when the other requirements are met. Minimum letter height by panel size: 1/16\" (\u22645 sq in), 1/8\" (>5, 25), 3/16\" (>25, 100), 1/4\" (>100 up to 400), 1/2\" (>400). Add 1/16\" if lettering is blown, embossed, or molded. We can't measure panel size or lettering from text, confirm this on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.13" }, { "requirement": "Clear space around the net quantity statement", "citation": "21 CFR 701.13(f)", "what_user_must_do": "Separate the net quantity from other printed label information above and below by at least the height of its lettering. Leave at least twice the width of its letter N to the left and right. Confirm this on the print artwork; the current PDF checks do not measure this clearance.", "can_engine_verify": false, "source_url": "https://www.ecfr.gov/current/title-21/section-701.13" }, { "requirement": "Statement of identity prominence and placement", "citation": "21 CFR 701.11", "what_user_must_do": "Show what the product is (common name, descriptive name, or an illustration) on the front panel as one of its main features, in bold type, sized in proportion to the most prominent text on that panel. We can't verify size or panel position from text, confirm this on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.11" }, { "requirement": "Ingredients in descending order of predominance", "citation": "21 CFR 701.3(a), (f)", "what_user_must_do": "List ingredients from most to least by amount. Exception: ingredients at 1% or less may appear in any order after those above 1%, and color additives may appear in any order at the end. We can't see your formula's concentrations from the label, so we can't verify the order, confirm it matches your formulation.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Ingredient lettering size / small-package options", "citation": "21 CFR 701.3", "what_user_must_do": "Ingredient lettering must meet the minimum height for your package size. Very small packages may place the ingredient list on a tag, tape, or card firmly affixed to the package, or on accompanying display material. We can't measure this from text, confirm on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Correct panel placement (front panel vs. information panel)", "citation": "21 CFR 701.3, 701.12, 701.13(e)", "what_user_must_do": "Net quantity goes on the front (principal display) panel; the ingredient list and the manufacturer/distributor name and address may go on an information panel. We check that this information is present in your text but can't tell which physical panel it's on, confirm panel placement on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.12" }, { "requirement": "Conspicuousness, contrast, and English", "citation": "21 CFR 701.2", "what_user_must_do": "All required statements must be in English and easy to find and read under normal shopping conditions, adequate type size, good contrast, not crowded. If any required statement also appears in another language, all required statements must appear in that language too. We can't assess size, contrast, or prominence from text; confirm on your packaging.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.2" }, { "requirement": "Safety-substantiation warning (if applicable)", "citation": "21 CFR 740.10", "what_user_must_do": "If your product's safety has not been adequately substantiated, the front panel must bear, word for word: \"Warning\u2014The safety of this product has not been determined.\" We can't tell from the label whether your safety data is on file, confirm whether this applies.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.10" }, { "requirement": "Tanning / self-tanner warning (if applicable)", "citation": "21 CFR 740.19", "what_user_must_do": "If your product is a suntanning preparation that does not contain a sunscreen, its labeling must display, word for word: \"Warning-This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.\" 21 CFR 740.19 defines \"suntanning preparations\" to include topical products that give a cosmetic effect on the skin while tanning under UV radiation and products that give the appearance of a tan with an approved colour additive such as dihydroxyacetone. We check this automatically when the label names the product as a tanning or self-tanning preparation, or declares dihydroxyacetone. If your product is one and uses wording we did not recognise, confirm this yourself.", "can_engine_verify": false, "source_url": "https://www.ecfr.gov/current/title-21/section-740.19" }, { "requirement": "Aerosol / pressurized-container warnings (if applicable)", "citation": "21 CFR 740.11", "what_user_must_do": "If your product is in a pressurized (aerosol) container, it must bear, word for word: \"Warning\u2014Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 \u00b0F. Keep out of reach of children.\" (Glass: use \"break\" for \"puncture\"; non-spray: omit \"Avoid spraying in eyes\"; children's: add \"except under adult supervision.\") If it uses a halocarbon or hydrocarbon propellant, also: \"Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.\"", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.11" }, { "requirement": "Warning-statement conspicuousness (type size, bold, contrast)", "citation": "21 CFR 740.2", "what_user_must_do": "Every warning statement must appear prominently and conspicuously compared to other words and designs, in bold type on contrasting background, likely to be read under customary conditions of purchase and use - and never in letters or numbers under 1/16 inch in height (unless FDA has granted a small-package exemption by regulation). We can verify a warning's TEXT is present but not its size, weight, or contrast; confirm these on your packaging artwork.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/740.2" }, { "requirement": "Tamper-resistant packaging for cosmetic liquid oral hygiene and vaginal products (if applicable)", "citation": "21 CFR 700.25", "what_user_must_do": "If this product is a cosmetic liquid oral hygiene product or a cosmetic vaginal product, and it is accessible to the public while held for sale, it must be packaged in a tamper-resistant retail package. Except for aerosol products, the retail package must also bear a statement, prominently placed, that alerts consumers to the specific tamper-resistant feature. (An oral-hygiene product marketed with a therapeutic claim is an OTC drug, not a cosmetic, and is covered by 21 CFR 211.132 instead.) A label-text scan cannot verify packaging, so confirm whether this applies to your product.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/700.25" }, { "requirement": "No prohibited cattle (BSE) materials in the formulation (if applicable)", "citation": "21 CFR 700.27", "what_user_must_do": "No cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials: specified risk materials, the small intestine of all cattle (unless the distal ileum has been removed by the procedure the regulation specifies), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef. The definition expressly EXCLUDES tallow containing no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, so most common bovine-derived cosmetic ingredients fall outside the ban. If your formula uses any other bovine-derived ingredient, confirm its sourcing with your supplier. A label scan cannot verify ingredient sourcing.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/700.27" }, { "requirement": "Ingredient declaration on multiunit and multicomponent packages (if applicable)", "citation": "21 CFR 701.3(q); 21 CFR 701.3(i)-(k)", "what_user_must_do": "21 CFR 701.3(q): the inside containers of a multiunit or multicomponent package need no ingredient declaration when the outer package bears one that meets this section and the inner units are not sold separately. Separately, 701.3(i)-(k) let a package with less than 12 square inches of label surface carry its declaration on a firmly affixed tag, tape or card, or in leaflet labeling on a display unit or chart; such a display unit must carry the words \"Federal law requires ingredient lists to be displayed here\" in letters not less than 3/16 inch high, conspicuous when no lists remain. Not applicable if the individual units' ingredient declarations are already visible through or on the display package. A label-text scan of a single product panel cannot tell whether this product is sold as part of such a display package.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "\"New ingredient list\" overlabeling notice on formulation changes (if applicable)", "citation": "21 CFR 701.3(n)", "what_user_must_do": "21 CFR 701.3(n) is a permission, not a general overlabel duty: when a shortage of a cosmetic ingredient forces a formulation change, packages already printed with the old declaration may still be used if the revised declaration appears either on a firmly affixed tag, tape, card or sticker bearing the conspicuous words \"new ingredient list\" in letters not less than 1/16 inch high, or on labeling inside an unsealed package whose outside bears \"new ingredient list inside\". Not applicable to a label being printed for the first time. A label-text scan cannot tell whether this PDF is such an overlabel.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "\"May contain\" color additive declaration for batch color-matching (if applicable)", "citation": "21 CFR 701.3(g)(1)", "what_user_must_do": "If a color additive is added to only SOME batches of this product for the purpose of color matching, you may declare it using the phrase \"may contain\" (e.g. \"May Contain: Red 33\") instead of listing it as though every batch contains it. This is an OPTIONAL labeling accommodation - a label that lists every color additive unconditionally is also compliant. A label-text scan cannot tell whether a given batch actually varies this way; confirm with your formulator which additives are batch-variable before using this declaration style.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Composite color-additive list for an assortment sold in one package (if applicable)", "citation": "21 CFR 701.3(h)", "what_user_must_do": "If this product ships as part of an assortment of cosmetics sold together in the same package, you may declare the COLOR ADDITIVES of the whole assortment in a single composite list - instead of a separate color-additive declaration for each product - as long as the listing is not misleading and makes clear it covers every product in the package. This applies to color additives only; the rest of the ingredient declaration follows the ordinary rules. A label-text scan of one product panel cannot tell whether it ships packaged together with others.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Cumulative ingredient list for an assortment of similar products (if applicable)", "citation": "21 CFR 701.3(o)", "what_user_must_do": "If this product is sold as part of an assortment of products similar in composition and intended for the same use (FDA's example is an eyeshadow palette), you may declare the ingredients common to all of them in a single cumulative list, together with a statement identifying which products contain the other, non-common ingredients - or, if the package's labelable surface is under 12 square inches, in one combined list with no separate non-common statement required. A label-text scan of one product panel cannot tell whether it ships as part of such an assortment.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Shared label declaration for a branded shade line (if applicable)", "citation": "21 CFR 701.3(g)(2), (o)(3)-(4)", "what_user_must_do": "If this product is one item in a branded shade line sold under a common trade name with no other brand appearing on any item (FDA's examples: one lipstick in a line of lipsticks, or one compact in a line of compacts), the line may share a single label declaring the ingredients common to all shades, plus a statement identifying the other, shade-specific ingredients and which product(s) contain them; shade-specific color additives may use the \"may contain\" declaration under 701.3(g)(2). A label-text scan of one shade's panel cannot tell whether it is part of such a line.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Direct-mail alternative ingredient declaration (if applicable)", "citation": "21 CFR 701.3(r)", "what_user_must_do": "If this product is sold to consumers by direct mail, the ingredient declaration may appear (letters not less than 1/16 inch high) in the accompanying mailing, sales catalog, or brochure instead of on the package, PROVIDED the mailed package itself carries a notice - visible on opening, letters not less than 3/16 inch high - that states where the declaration is located, promises a copy will be mailed promptly on request, and gives the mail-order distributor's name and place of business; the distributor must then actually fulfill that promise when asked. A label-text scan of the package panel cannot tell whether this product is sold by direct mail or whether the required catalog/brochure declaration exists.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "Off-package leaflet ingredient declaration for small/compartmented display units (if applicable)", "citation": "21 CFR 701.3(i)-(k)", "what_user_must_do": "If this product's package has under 12 square inches of labelable surface (and is not enclosed in an outer carton), the ingredient declaration may instead appear (letters not less than 1/16 inch high) on an accompanying leaflet attached to a compartmented display tray or rack - or, for a shade-matched assortment, attached to a display chart bearing shade samples - rather than on each unit. Strict conditions apply: the leaflet must be visible per specific placement rules (fully readable from the front, or accompanied by a 3/16-inch notice if partially visible or on a side); all copies used with one display must be identical; the unit must ship together with its labeling; the display must show \"Federal law requires ingredient lists to be displayed here\" (3/16 inch minimum) whenever no declaration is currently attached; a formulation change requires the leaflet to be dated and to distinguish old vs. new formula; sufficient copies must be provided for every purchaser; and the firm named on the product must mail a copy to anyone who requests one. A label-text scan of one product's panel cannot tell whether it is sold this way or whether the display unit meets these conditions.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "requirement": "CPSIA lead and phthalate limits for children's cosmetics/packaging (if applicable)", "citation": "15 U.S.C. \u00a7 1278a; 16 CFR 1303.2; 16 CFR 1307.2-.3", "what_user_must_do": "If this product, its packaging, or an accessory (e.g. an applicator) is a children's product as defined by the CPSIA, or has any paint or similar surface coating, two federal chemical limits apply: (1) total lead content in any accessible substrate material may not exceed 100 ppm (15 U.S.C. \u00a7 1278a), and lead in paint or similar surface coatings may not exceed 0.009% / 90 ppm (16 CFR 1303.2); (2) a children's toy or child care article may not contain more than 0.1% of any of eight prohibited phthalates - DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP (16 CFR 1307.2-.3) - applying equally to toys and child care articles, no mouth-contact or age distinction. DIDP and DnOP, part of the ORIGINAL 2008 interim ban, are NOT on the current permanent list and are not restricted by this rule today. These are formula/material composition facts a label-text scan cannot see - confirm testing with your supplier if this product is marketed to or usable by children.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/cfr/text/16/1307.3" }, { "requirement": "Country-of-origin marking for imported product (if applicable)", "citation": "19 U.S.C. \u00a7 1304(a)", "what_user_must_do": "If this product is of foreign origin, the ARTICLE itself - not merely the shipping carton - must be marked in a conspicuous place, as legibly, indelibly and permanently as the nature of the article will permit, with the English name of the country of origin, for example \"Made in France\". We raise a specific finding automatically only when the label carries a non-US address and we find no origin mark on it. Whether the product is in fact imported, and whether the physical marking is conspicuous, indelible and permanent enough, are facts about the finished package that a label-text scan cannot determine, so confirm both with your manufacturer. If the article is made in the United States, this statute requires no marking.", "can_engine_verify": false, "source_url": "https://www.law.cornell.edu/uscode/text/19/1304" } ], "unsupported_reasons": [], "supplier_documents": [], "retailer_document_kits": { "amazon": [ { "name": "Supplier or manufacturer invoice dated within the last 180 days", "why": "Amazon requires a recent invoice to establish an authentic chain of custody for the product.", "conditional": false }, { "name": "Certificate of Analysis (COA) from an accredited lab", "why": "Provides test evidence for the substances and limits actually tested. Check the lot, method, scope and retailer request; it is not a blanket compliance certificate.", "conditional": false }, { "name": "Good Manufacturing Practice (GMP) certificate", "why": "Provides evidence about the manufacturing practices covered by the certificate or audit. Confirm its scope, validity and the retailer's requirements.", "conditional": false }, { "name": "Full INCI ingredient list matching the corrected label", "why": "Amazon cross-checks the declared ingredients against its restricted-substances list.", "conditional": false }, { "name": "Safety Data Sheet (SDS) for the finished formulation", "why": "Standard safety documentation reviewers request for cosmetics.", "conditional": false }, { "name": "Clear photos of the corrected packaging and label (all panels)", "why": "Restricted-products reviews accept corrected-label photos as primary evidence that the issue is fixed.", "conditional": false }, { "name": "Proof of California Safe Cosmetics Program (CSCP) reporting", "why": "Requested when the product is sold into California and contains a reportable ingredient.", "conditional": true } ] }, "zones": [ { "kind": "pdp", "basis": "leading_block", "start": 0, "end": 90, "excerpt": "Radiance Face Serum\nSoothes and improves the look of skin.\n\nNet Contents 1 fl oz (30 mL)" }, { "kind": "ingredients", "basis": "header", "header": "Ingredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol.", "start": 90, "end": 154, "excerpt": "Ingredients: Water, Glycerin, Phenoxyethanol, Caprylyl Glycol." }, { "kind": "directions", "basis": "header", "header": "Directions: Apply a small amount to clean skin.", "start": 154, "end": 203, "excerpt": "Directions: Apply a small amount to clean skin." }, { "kind": "warnings", "basis": "header", "header": "Warnings:", "start": 203, "end": 387, "excerpt": "Warnings:\nKeep out of reach of children.\nAvoid contact with eyes. If contact occurs, rinse thoroughly with water.\nFor external use only.\nDiscontinue use if irri" }, { "kind": "manufacturer", "basis": "header", "header": "Manufactured by Example Beauty, 100 Example St, Austin, TX 78701", "start": 387, "end": 511, "excerpt": "Manufactured by Example Beauty, 100 Example St, Austin, TX 78701\n\nQuestions or adverse event reports: safety@example.invalid" } ], "concentration_notes": [], "semantic_findings": [], "semantic_status": "disabled", "label_id": 1, "scan_id": 2, "created_at": "2026-09-15 13:16:43", "workflow_state": "completed", "version_number": 2, "auto_tasks_created": 0, "ocr_provider": null, "ocr_confidence": null, "checks_performed": [ { "code": "701.11.identity_present", "title": "Identity statement present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.13.net_quantity_present", "title": "Net quantity of contents present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.3.ingredients_heading", "title": "Ingredient declaration present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.12.manufacturer_present", "title": "Manufacturer or distributor present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "warnings.eye_contact", "title": "Eye-contact warning (best practice)", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "warnings.children_best_practice", "title": "Children safety warning (best practice)", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.2.english_required", "title": "Required information appears in English", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "warnings.flammable", "title": "Flammability warning if applicable", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.aha_warning", "title": "AHA sun sensitivity warning recommended", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.prostaglandin_lash", "title": "Prostaglandin analog in a lash or brow product: unapproved prescription drug", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.salicylic_acid_acne", "title": "Salicylic acid above 2% in an acne product: unapproved new drug", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.unapproved_drug.anesthetic_active", "title": "Anesthetic active declared without a Drug Facts panel", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.kohl_kajal_surma", "title": "FDA prohibited: kohl, kajal, al-kahal or surma", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.marine_mammal_derived", "title": "Cetacean-derived ingredient: prohibited from US commerce", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "MBFWA.microbeads_prohibited", "title": "Plastic microbeads prohibited in rinse-off cosmetics", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.bithionol", "title": "FDA prohibited ingredient: Bithionol", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.chloroform", "title": "FDA prohibited ingredient: Chloroform", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.halogenated_salicylanilides", "title": "FDA prohibited ingredient: Halogenated salicylanilides", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.methylene_chloride", "title": "FDA prohibited ingredient: Methylene chloride", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.vinyl_chloride", "title": "FDA prohibited ingredient: Vinyl chloride", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.prohibited.cfc_propellants", "title": "FDA prohibited ingredient: Chlorofluorocarbon propellants", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FDA.restricted.zirconium_aerosol", "title": "FDA restricted ingredient: Zirconium compounds in aerosol cosmetics", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "FDA.restricted.hexachlorophene", "title": "FDA restricted ingredient: Hexachlorophene", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "FDA.restricted.mercury", "title": "FDA restricted ingredient: Mercury compounds", "status": "pass", "category": "ingredient_restrictions", "evaluation_state": "pass" }, { "code": "COLOR.unapproved_additive", "title": "Color additive not on the FDA approved lists", "status": "pass", "category": "color_additives", "evaluation_state": "pass" }, { "code": "COLOR.fdc_red_3_terminated", "title": "FD&C Red No. 3 - cosmetic listing terminated", "status": "pass", "category": "color_additives", "evaluation_state": "pass" }, { "code": "warnings.external_use_only", "title": "'For external use only' warning recommended (best practice)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing chemical actives that warrant an external-use statement. None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "warnings.discontinue_if_irritation", "title": "'Discontinue use if irritation occurs' warning recommended (best practice)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing strong actives (retinol, salicylic acid, benzoyl peroxide and similar). None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "warnings.hair_dye_warning", "title": "Coal-tar hair dye caution required (FD&C Act \u00a7 601 / 21 U.S.C. \u00a7 361)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to coal-tar hair dye products. No hair dye ingredient (p-phenylenediamine, resorcinol, aminophenol) is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "detergent_label", "title": "Eye contact warning recommended for surfactant-based product", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to surfactant-based products. No surfactant (SLS, SLES, cocamidopropyl betaine) is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.feminine_deodorant_caution", "title": "Feminine deodorant spray mandatory caution (21 CFR 740.12(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to feminine deodorant sprays (21 CFR 740.12). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.feminine_hygiene_term", "title": "\"Hygiene\" wording barred on feminine deodorant sprays (21 CFR 740.12(c))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to feminine deodorant sprays (21 CFR 740.12). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.foaming_bath_caution", "title": "Foaming/bubble bath mandatory caution (21 CFR 740.17(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to foaming/bubble bath products (21 CFR 740.17). This label does not represent the product as one. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.tamper_evident_statement", "title": "Tamper-resistant packaging statement (21 CFR 700.25)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetic liquid oral hygiene products (mouthwash, oral rinse) and vaginal products (21 CFR 700.25), and only when they are cosmetics. Either this label does not represent the product as either -- toothpaste is not a LIQUID oral hygiene product and is outside the regulation -- or the label carries a Drug Facts panel, in which case the product is an OTC drug and the equivalent tamper-evident packaging duty sits at 21 CFR 211.132 instead. That is the authority to work from. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_term_qualifier", "title": "\"Sunscreen\" terminology on a cosmetic must be qualified (21 CFR 700.35)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetic labels that use the term \"sunscreen\" or similar sun-protection terminology without SPF/Drug Facts labeling. This label does not. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.suntanning_warning", "title": "Suntanning preparation warning without a sunscreen (21 CFR 740.19)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to suntanning and self-tanning preparations (21 CFR 740.19). This label does not represent the product as one and declares no dihydroxyacetone. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.self_pressurized_warning", "title": "Self-pressurized (aerosol) container warning (21 CFR 740.11(a))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to cosmetics packaged in a self-pressurized (aerosol) container (21 CFR 740.11). Nothing on this label indicates a pressurized container or a propellant. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.aerosol_propellant_misuse_warning", "title": "Aerosol propellant intentional-misuse warning (21 CFR 740.11(b))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to self-pressurized products whose propellant is a halocarbon or a hydrocarbon (21 CFR 740.11(b)). No such propellant is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "701.13.parenthetical_restatement", "title": "Net quantity \u2265 1 lb / 1 pt needs a parenthetical restatement (21 CFR 701.13(j)(1))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.13.fraction_form", "title": "Net quantity fraction denominator (21 CFR 701.13(d))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.13.abbreviation_form", "title": "Net quantity abbreviation form (21 CFR 701.13(n))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.13.exaggerating_qualifier", "title": "Net quantity exaggerating qualifier (21 CFR 701.13(q); 15 U.S.C. \u00a7 1453(b))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.2.english_required_elements", "title": "Required label element appears in Spanish but not English (21 CFR 701.2(b)(1))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.12.manufacturer_address_incomplete", "title": "Manufacturer place of business complete: street, city, state, ZIP (21 CFR 701.12(d))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "FPLA.net_quantity_format", "title": "Net quantity states both US customary and metric units (15 U.S.C. \u00a7 1453(a)(2))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.3.ingredients_comma_separated", "title": "Ingredient list uses the standard comma-separated format (21 CFR 701.3(a))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "701.2.foreign_language_consistency", "title": "Required label information appears in any foreign language used (21 CFR 701.2(b))", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "EPA.hcfc_ozone_warning", "title": "Ozone-depletion warning present for HCFC-containing products (40 CFR 82.106)", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "CA.prop65.required", "title": "California Prop 65 warning may be required", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.prop65.warning_format", "title": "Prop 65 warning does not match the safe-harbor format", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CA.pfas_restriction", "title": "California PFAS prohibition in cosmetics (AB 2771)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CA.ab2762.sale_ban", "title": "Banned for sale in California: Toxic-Free Cosmetics Act (AB 2762)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "MD.hb643.named_ban", "title": "Banned for sale in Maryland: Cosmetic Products Ingredient Prohibition (HB 643)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b", "title": "Banned for sale in California (2027): Toxic-Free Cosmetics Act expansion", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.monomers", "title": "Banned for sale in California (2027): styrene / vinyl acetate monomer", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980c.musk_ketone", "title": "Musk ketone capped in California (2027): concentration limits by product type", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.boron", "title": "Banned for sale in California (2027): boron compounds (boric acid / borates)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "CA.hsc108980b.laurus_seed", "title": "Banned for sale in California (2027): Laurus nobilis seed oil", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WI.mercury_prohibition", "title": "Wisconsin mercury prohibition in cosmetics, toiletries and fragrance products", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "LA.mercury_limit", "title": "Louisiana mercury limit in cosmetics (10 ppm)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NY.mercury_restriction", "title": "New York mercury prohibition in cosmetics", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NY.hair_relaxer_warning", "title": "New York hair-relaxer carcinogen warning (takes effect May 21, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "MN.pfas_restriction", "title": "Minnesota PFAS restriction in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "MN.mercury_prohibition", "title": "Minnesota mercury prohibition in cosmetics, toiletries and fragrances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "MN.childrens_formaldehyde_ban", "title": "Minnesota formaldehyde ban in children's products (under age 8)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "WA.toxic_free_cosmetics", "title": "Washington Toxic-Free Cosmetics Act", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WA.toxic_free_cosmetics.ortho_phthalate_class", "title": "Washington ortho-phthalate class ban in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "WA.pfas_restriction", "title": "Washington PFAS restriction in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NJ.pfas_restriction", "title": "New Jersey PFAS class ban in cosmetics (takes effect Jan 12, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CT.pfas_restriction", "title": "Connecticut PFAS restriction in cosmetics (label-and-notify since Jul 1, 2026; full ban Jan 1, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "RI.pfas_restriction", "title": "Rhode Island PFAS class ban in cosmetics (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "WA.formaldehyde_releasers", "title": "Washington formaldehyde releaser ban in cosmetics (takes effect Jan 1, 2027)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "WA.formaldehyde_releasers.timonacic_straightener", "title": "Washington formaldehyde releaser (timonacic): heat-activated hair straighteners (takes effect Jan 1, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "CO.pfas_restriction", "title": "Colorado PFAS prohibition in cosmetics", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CO.hair_relaxer_warning", "title": "Colorado hair relaxer carcinogen warning (takes effect July 1, 2027)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "MD.pfas_restriction", "title": "Maryland PFAS prohibition in cosmetics (HB 643)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "ME.pfas_restriction", "title": "Maine PFAS prohibition in cosmetics (LD 1537)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.pfas_restriction", "title": "Vermont PFAS prohibition in cosmetics (S.25 / Act 131)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.sale_ban", "title": "Banned for sale in Vermont: Act 131 named substances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "VT.act131.ortho_phthalate_class", "title": "Vermont Act 131 ortho-phthalate class ban", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "VT.act131.2027", "title": "Banned for sale in Vermont (2027): Act 131 styrene / D4 / toluene", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "HI.environmental_disclosure", "title": "Hawaii reef-safe sunscreen law: oxybenzone and octinoxate prohibited", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "status": "advisory", "category": "state", "reason": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility.", "evaluation_state": "advisory" }, { "code": "OR.sb546.sale_ban", "title": "Oregon SB 546 cosmetics sale ban: named substances (takes effect Jan 1, 2027)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "OR.sb546.ortho_phthalate_class", "title": "Oregon SB 546 ortho-phthalate class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "OR.sb546.pfas_restriction", "title": "Oregon SB 546 PFAS class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "NM.pfas_restriction", "title": "New Mexico PFAS class ban in cosmetics (takes effect Jan 1, 2028)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "IL.cosmetics_act.named_ban", "title": "Banned for sale in Illinois: Chemicals in Cosmetic Products Act (takes effect Jul 1, 2028)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "IL.pfas_restriction", "title": "Illinois PFAS ban in cosmetics (13 enumerated Jul 1, 2028; whole class Jan 1, 2032)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "IL.mercury_prohibition", "title": "Illinois mercury prohibition in cosmetics, toiletries and fragrances", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "AR.hair_relaxer_warning", "title": "Arkansas hair-relaxer carcinogen warning (in force since 2025)", "status": "not_applicable", "category": "state", "evaluation_state": "not_applicable" }, { "code": "VA.toxin_free.named_ban", "title": "Banned for sale in Virginia: Humane and Toxin-Free Cosmetics Act (HB 122)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "VA.pfas_restriction", "title": "Virginia PFAS prohibition in cosmetics (HB 122)", "status": "pass", "category": "state", "evaluation_state": "pass" }, { "code": "NH.pfas_restriction", "title": "New Hampshire PFAS prohibition in cosmetics (2027)", "status": "advisory", "category": "state", "evaluation_state": "advisory" }, { "code": "CLM.drug_treats", "title": "Drug claim: 'treats' a condition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.drug_cures", "title": "Drug claim: 'cures' or 'heals'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.antibacterial", "title": "Drug claim: antibacterial / antimicrobial", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.antiseptic", "title": "Drug claim: antiseptic", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.antifungal", "title": "Drug claim: antifungal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_repellent", "title": "Pesticide claim: insect/pest repellent", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_disinfectant", "title": "Pesticide/drug claim: disinfects or sanitizes", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pesticide_mold", "title": "Pesticide claim: kills or prevents mold/mildew", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.anti_dandruff", "title": "Drug claim: anti-dandruff", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.spf_no_drug_facts", "title": "SPF claim requires Drug Facts panel", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.acne_treatment", "title": "Drug claim: acne treatment", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.dna_repair", "title": "Drug claim: DNA repair", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.prevents_hair_loss", "title": "Drug claim: hair loss prevention / regrowth", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.wound_healing", "title": "Drug claim: wound healing", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.collagen_stimulation", "title": "Drug claim: stimulates collagen or elastin", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.anti_inflammatory", "title": "Drug claim: anti-inflammatory", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.clinically_proven", "title": "Substantiation required: 'clinically proven / tested'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.quantified_performance", "title": "Substantiation required: quantified performance claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.procedure_comparison", "title": "Substantiation required: comparison to a medical procedure", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.dermatologist_approved", "title": "Substantiation required: dermatologist claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.expert_professional_recommended", "title": "Substantiation required: physician / medical-professional endorsement claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.hundred_percent_natural", "title": "Advisory: '100% natural': no regulatory standard", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.organic_uncertified", "title": "Substantiation required: 'organic' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.reef_safe", "title": "Substantiation required: 'reef safe'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_general", "title": "Substantiation required: general environmental benefit claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_biodegradable", "title": "Substantiation required: 'biodegradable'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_compostable", "title": "Substantiation required: 'compostable'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_recyclable", "title": "Substantiation required: 'recyclable' / recycled content", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_nontoxic", "title": "Substantiation required: 'non-toxic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_ozone", "title": "Substantiation required: 'ozone-safe' / 'ozone-friendly'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_carbon", "title": "Substantiation required: carbon-neutral / net-zero claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_sustainable", "title": "Substantiation required: 'sustainable' / renewable materials", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.green_certification_seal", "title": "Substantiation required: third-party certification / seal claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.certified_nontoxic_seal", "title": "Substantiation required: \"Certified Non-Toxic\" / safety-certification seal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.safe_for_children", "title": "Substantiation required: \"safe for kids/tweens/teens\"", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.refillable", "title": "Substantiation required: 'refillable' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.renewable_energy", "title": "Substantiation required: renewable energy claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.free_of_unassociated_substance", "title": "'Free-of' claim names a substance never associated with this product type", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.made_in_usa", "title": "Substantiation required: 'Made in USA'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.cruelty_free", "title": "Substantiation required: 'cruelty-free' / 'not tested on animals'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.vegan", "title": "Substantiation required: 'vegan'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.gluten_free", "title": "Substantiation required: 'gluten-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.gmo_free", "title": "Substantiation required: 'non-GMO' / 'GMO-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.unscented", "title": "Substantiation required: 'unscented' (not the same as fragrance-free)", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.award_winning", "title": "Substantiation required: award / best-seller claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.usda_organic_seal", "title": "Substantiation required: 'USDA Organic' claim", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.fda_approved_cosmetic", "title": "False claim: 'FDA approved' for a cosmetic", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.eliminates_permanently", "title": "Drug claim: 'eliminates' or 'permanently' + skin condition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.hypoallergenic", "title": "Substantiation required: 'hypoallergenic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.non_comedogenic", "title": "Substantiation required: 'non-comedogenic'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_eczema", "title": "Drug claim: names eczema / dermatitis", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_psoriasis", "title": "Drug claim: names psoriasis", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_rosacea", "title": "Drug claim: names rosacea", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_melasma", "title": "Drug claim: names melasma / chloasma", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_keratosis", "title": "Drug claim: names keratosis (incl. keratosis pilaris)", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_barrier_repair", "title": "Drug claim: repairs / rebuilds the skin barrier", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_cell_regeneration", "title": "Drug claim: regenerates cells / cell renewal", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.prescription_strength", "title": "Drug claim: prescription / Rx-strength", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.comparative_prescription", "title": "Drug claim: compares efficacy to prescription products", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.medical_grade", "title": "Misleading: 'medical-grade' / 'cosmeceutical'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.sf_detox", "title": "Misleading: 'detoxifies' skin", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.timeframe_results", "title": "Substantiation required: results within a stated timeframe", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.skin_bleaching", "title": "Drug claim: skin whitening / bleaching / lightening", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_vitiligo", "title": "Drug claim: names vitiligo", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_warts", "title": "Drug claim: names warts", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_cold_sore", "title": "Drug claim: names cold sores / herpes", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_fungal", "title": "Drug claim: names a fungal condition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.condition_lice", "title": "Drug claim: head lice / pediculicide", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.oral_anticaries", "title": "Drug claim: cavity / tooth-decay / gingivitis prevention", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.pore_shrink", "title": "Misleading: shrinks / tightens pores", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.cellulite", "title": "Misleading: reduces / eliminates cellulite", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.uv_protection", "title": "Drug claim: UV / sun protection without sunscreen drug labeling", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.lash_growth", "title": "Drug claim: eyelash or eyebrow growth", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.scar_treatment", "title": "Drug claim: treats or removes scars", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.stretch_mark_treatment", "title": "Drug claim: removes or prevents stretch marks", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.topical_anesthetic", "title": "Drug claim: numbing or pain relief", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "CLM.reverses_aging", "title": "Drug claim: reverses aging or sun damage", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.chemical_free", "title": "Misleading: 'chemical-free'", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.clean_beauty", "title": "Advisory: 'clean' has no regulatory definition", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "MKT.anti_pollution", "title": "Substantiation required: anti-pollution / blue-light protection", "status": "pass", "category": "claims", "evaluation_state": "pass" }, { "code": "FDA.unapproved_otc_drug", "title": "Not-GRASE active ingredient: unapproved new drug under FD&C 505(a)", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products containing an OTC drug active ingredient. None is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_not_grase", "title": "Not-GRASE sunscreen active: not legally marketable under OTC monograph", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to OTC sunscreen products. No sunscreen active ingredient is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.sunscreen_cat3_pending", "title": "Chemical sunscreen actives with pending FDA GRASE determination", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens containing chemical UV filters with a pending FDA GRASE determination. No sunscreen active ingredient is declared on this label. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.broad_spectrum_test", "title": "'Broad Spectrum' claim requires documented Critical Wavelength test", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens making a \u201cBroad Spectrum\u201d claim. This label makes no sunscreen claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.water_resistance_label", "title": "Water resistance labeling: prohibited terms or missing required duration", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens making a water-resistance claim. This label makes no sunscreen claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "FDA.spf_skin_cancer_alert", "title": "Skin Cancer/Skin Aging Alert required for non-Broad-Spectrum or SPF < 15 sunscreens", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to sunscreens with SPF below 15 or without Broad Spectrum protection. This label makes no SPF claim. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "MOCRA.adverse_event_contact", "title": "Domestic contact for adverse event reports present", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "mocra.responsible_person_non_us", "title": "Non-US distributor address: confirm MoCRA facility registration and US agent", "status": "pass", "category": "federal", "evaluation_state": "pass" }, { "code": "mocra.professional_use_statement", "title": "Professional-use product carries the licensed-professionals statement (21 U.S.C. \u00a7 364e(c))", "status": "not_applicable", "category": "federal", "reason": "Not applicable. This rule applies to products the label restricts to professional or salon use (21 U.S.C. \u00a7 364e(c)). This label carries no such use restriction. This does not affect your compliance result.", "evaluation_state": "not_applicable" }, { "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "status": "advisory", "category": "ingredient_restrictions", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "status": "advisory", "category": "ingredient_restrictions", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "PKG.toxics_in_packaging", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "status": "advisory", "category": "packaging", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "IH.restricted_preservative.phenoxyethanol", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "status": "advisory", "category": "ingredient_hazards", "evidence": "", "is_finding": true, "evaluation_state": "advisory" }, { "code": "AMZ.ingredients_present", "title": "Full ingredient list required", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.net_quantity", "title": "Net quantity required on listing", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.no_drug_claims", "title": "No drug or therapeutic claims permitted", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.manufacturer_info", "title": "Manufacturer or responsible party required", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "category": "retailer_amazon", "status": "advisory", "evaluation_state": "advisory" }, { "code": "AMZ.no_formaldehyde", "title": "Formaldehyde and releasers restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.no_mercury", "title": "Mercury compounds restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.spf_otc_compliance", "title": "SPF products must comply with OTC drug monograph", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_triclosan", "title": "Triclosan restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_parabens", "title": "Propyl- and butyl-parabens restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_phthalates", "title": "Phthalates restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_npe", "title": "Nonylphenol and NP ethoxylates restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_pfas", "title": "Perfluorinated chemicals restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.marketplace_concentration_caps", "title": "Concentration cap exceeded (Amazon marketplace policy)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_misc", "title": "Other RSL substances restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" }, { "code": "AMZ.rsl_microplastics", "title": "Microplastics restricted (Amazon Private Brand RSL)", "category": "retailer_amazon", "status": "pass", "evaluation_state": "pass" } ], "scan_duration_ms": 259, "engine_version": "2.0.0", "rules_library_version": "v187.0b52d7", "ruleset_version": "2026.09.13", "git_sha": "1473b00", "rules_as_of": "2026-08-04", "regulatory_as_of": {}, "covered_regimes": [], "include_eu": false, "retailer_status": { "amazon": "pass" }, "retailer_not_covered_reasons": null, "entitled": true, "credit_balance": 0, "plan": "pro", "checks_performed_count": 204, "ih_findings_count": 1, "not_screened_count": 0, "claims_not_screened_count": 0, "extraction_unverified_not_screened_count": 0, "claims_error_count": 0, "claims_warning_count": 0, "manual_review_count": 35, "manual_review": [ { "kind": "class_ban_advisory", "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "what_to_verify": "California, Colorado, Connecticut, Illinois, Maine, Minnesota, New Hampshire, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington prohibit or restrict intentionally added PFAS in cosmetics; effective dates vary by state and each state's own finding gives its date. These are class-wide bans, so a label-text scan cannot certify the absence of all PFAS, many are undeclared or appear under trade names. No listed PFAS substance was detected on this label. Confirm with your formulator that no PFAS is intentionally added.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "what_to_verify": "Oregon, Vermont and Washington prohibit intentionally added ortho-phthalates in cosmetics; effective dates vary by state and each state's own finding gives its date. This is a class-wide ban and some ortho-phthalates are undisclosed under \"fragrance\", so a label-text scan cannot certify their absence. No phthalate was detected by name on this label. Confirm your formulation contains no intentionally added ortho-phthalates.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "PKG.toxics_in_packaging", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "what_to_verify": "Nineteen states have adopted the CONEG/TPCH Toxics in Packaging model law (count per the Toxics in Packaging Clearinghouse fact sheet, rev. Nov 2023). These limit lead, cadmium, mercury and hexavalent chromium in a package or packaging component to 100 parts per million by weight, stated as a combined total in every one of them except Iowa, whose text says only 'the concentration levels'. Five are verified against primary text: Florida (Fla. Stat. 403.7191(3)), Iowa (Iowa Code 455D.19(3)-(4)), Missouri (RSMo 260.822), Pennsylvania (Safe Packaging Act, Act of Dec. 7, 1994, P.L. 797, No. 112, sec. 301), Wisconsin (Wis. Stat. 100.285(2)). Georgia (O.C.G.A. 12-8-162) is included on a secondary reproduction only, not the official code. The 100 ppm tier is in force in all six. NOTE Wisconsin attaches NO PENALTY to its limit (Wis. Stat. 100.285(5)). Only PENNSYLVANIA prohibits INTENTIONAL introduction outright regardless of concentration; Georgia and Iowa carry that clause but gate it on also exceeding the agency-set level, and Florida, Wisconsin and Missouri have no such clause at all. SCOPE: this regulates the PACKAGE, expressly including inks, labels, coatings and closures, NOT the product formula. It therefore cannot be verified or violated by label text, and this scan does not check it.", "citation_url": "https://www.toxicsinpackaging.org" }, { "kind": "class_ban_advisory", "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "what_to_verify": "California Safe Cosmetics Program (CSCP): if your company's annual cosmetic sales exceed $1M AND this product contains any chemical on the CDPH Reportable Ingredients List (thousands of chemicals across 22 hazard lists, Prop 65, IARC, NTP, EPA, and EU classifications), you must report it to CDPH at cscpsubmit.cdph.ca.gov. This is a corporate reporting obligation, not an on-label requirement, and it cannot be determined from label text alone, it does not affect whether this label is compliant. Verify your reporting status with CDPH if the revenue threshold applies.", "citation_url": "https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=111792" }, { "kind": "class_ban_advisory", "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "what_to_verify": "New York caps 1,4-dioxane at 10 ppm in cosmetics and 1 ppm in personal care products (ECL Article 37 Title 1, \u00a7 37-0117(3)-(4); 6 NYCRR Subpart 352-1). It is a manufacturing impurity of ethoxylated ingredients (PEGs, -eth- surfactants, polysorbates), never a declared ingredient, so a label scan cannot verify the threshold. If your formula uses ethoxylated ingredients, obtain a 1,4-dioxane test report from your supplier, rinse-off personal care products face the tighter 1 ppm limit.", "citation_url": "https://dec.ny.gov/environmental-protection/pollution-prevention/household-personal-cosmetic-dioxane-limits" }, { "kind": "class_ban_advisory", "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "what_to_verify": "Minnesota caps lead at 90 ppm and cadmium at 75 ppm by total weight in cosmetics and personal care products (Minn. Stat. \u00a7 325E.3892). These are total-content limits, not declared-ingredient limits: colorant and pigment impurities can carry either metal below declaration level. No lead or cadmium compound is declared on this label, but a label scan cannot verify total content - obtain a heavy-metals certificate of analysis from your pigment and raw-material suppliers.", "citation_url": "https://www.revisor.mn.gov/statutes/cite/325E.3892" }, { "kind": "class_ban_advisory", "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "what_to_verify": "Vermont Act 131 (9 V.S.A. \u00a72494b, eff. Jan 1, 2026) bans 1,4-dioxane (>=10 ppm) and asbestos. These are typically undeclared contaminants (dioxane an impurity, asbestos a talc contaminant), so a label scan cannot certify their absence and the 10 ppm dioxane threshold is not verifiable from text. Confirm via supplier documentation / testing that 1,4-dioxane is below 10 ppm and no asbestos is present.", "citation_url": "https://legislature.vermont.gov/statutes/section/09/063/02494b" }, { "kind": "class_ban_advisory", "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "what_to_verify": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility.", "citation_url": "https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html" }, { "kind": "class_ban_advisory", "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "what_to_verify": "Oregon SB 546 formaldehyde-releasing-agent ban (eff. Jan 1, 2027): SB 546 \u00a74 bans this category generically (no statutory list). The scan checks a representative set of common formaldehyde donors; a no-match does not certify absence of every releasing agent. Before Jan 1, 2027 confirm your preservation system releases no formaldehyde (Oregon SB 546, \u00a74).", "citation_url": "https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/SB546/Enrolled" }, { "kind": "class_ban_advisory", "code": "IH.restricted_preservative.phenoxyethanol", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "what_to_verify": "Phenoxyethanol is on our watch list, but NO US federal or state rule we screen restricts it in cosmetics today, so this is not a violation and nothing on your label has to change because of it. Phenoxyethanol is flagged as a potential hazard (restricted preservative). Widely used cosmetic preservative. EU Annex V Entry 29: maximum 1.0%; no product-type restriction. Japan: 1.0% maximum in cosmetics under MHLW regulation. US: No 21 CFR prohibition. FDA issued a product-specific consumer warning in 2008 concerning Mommy's Bliss Nipple Cream containing phenoxyethanol + chlorphenesin, phenoxyethanol can depress the CNS and cause vomiting and diarrhea in infants via direct nipple-cream exposure. NOT a general FDA advisory on phenoxyethanol. Not Prop 65 listed. Flagged under some clean beauty retailer standards. Raise it with your formulator if the concern matters for your product or your retailer's own standards.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "what_to_verify": "Amazon's cosmetics listing requirements ask that units display identifying codes such as lot or serial numbers, and an expiration date for products with a shelf life under three years or otherwise a period-after-opening symbol such as '12M'. A lot code is usually a fill-line inkjet or laser mark and the PAO symbol is a pictogram, so neither can be verified from label text; this note appears on every Amazon check rather than reporting a false absence. Amazon's own cosmetics help page is behind a Seller Central sign-in.", "citation_url": null }, { "kind": "format_requirement", "code": "21 U.S.C. \u00a7 364e(c) (FD&C Act \u00a7 609)", "title": "Professional-use-only products must state they are for use only by licensed professionals", "what_to_verify": "If this product is distributed for use only by professionals, add a clear, prominent statement that it is to be used only by licensed professionals (cosmetology, nail care, barbering, or esthetics). A label scan cannot certify whether a product is professional-distribution-only, so confirm this applies to your product.", "citation_url": "https://uscode.house.gov/view.xhtml?req=(title:21%20section:364e%20edition:prelim)" }, { "kind": "format_requirement", "code": "21 CFR 701.13(e), (f), (i)", "title": "Net quantity placement and lettering size", "what_to_verify": "Put the net quantity on the front (principal display) panel, in the bottom 30% of that panel, parallel to the base. The bottom-30% placement requirement does not apply to panels of 5 square inches or less when the other requirements are met. Minimum letter height by panel size: 1/16\" (\u22645 sq in), 1/8\" (>5, 25), 3/16\" (>25, 100), 1/4\" (>100 up to 400), 1/2\" (>400). Add 1/16\" if lettering is blown, embossed, or molded. We can't measure panel size or lettering from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.13(f)", "title": "Clear space around the net quantity statement", "what_to_verify": "Separate the net quantity from other printed label information above and below by at least the height of its lettering. Leave at least twice the width of its letter N to the left and right. Confirm this on the print artwork; the current PDF checks do not measure this clearance.", "citation_url": "https://www.ecfr.gov/current/title-21/section-701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.11", "title": "Statement of identity prominence and placement", "what_to_verify": "Show what the product is (common name, descriptive name, or an illustration) on the front panel as one of its main features, in bold type, sized in proportion to the most prominent text on that panel. We can't verify size or panel position from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.11" }, { "kind": "format_requirement", "code": "21 CFR 701.3(a), (f)", "title": "Ingredients in descending order of predominance", "what_to_verify": "List ingredients from most to least by amount. Exception: ingredients at 1% or less may appear in any order after those above 1%, and color additives may appear in any order at the end. We can't see your formula's concentrations from the label, so we can't verify the order, confirm it matches your formulation.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3", "title": "Ingredient lettering size / small-package options", "what_to_verify": "Ingredient lettering must meet the minimum height for your package size. Very small packages may place the ingredient list on a tag, tape, or card firmly affixed to the package, or on accompanying display material. We can't measure this from text, confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3, 701.12, 701.13(e)", "title": "Correct panel placement (front panel vs. information panel)", "what_to_verify": "Net quantity goes on the front (principal display) panel; the ingredient list and the manufacturer/distributor name and address may go on an information panel. We check that this information is present in your text but can't tell which physical panel it's on, confirm panel placement on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12" }, { "kind": "format_requirement", "code": "21 CFR 701.2", "title": "Conspicuousness, contrast, and English", "what_to_verify": "All required statements must be in English and easy to find and read under normal shopping conditions, adequate type size, good contrast, not crowded. If any required statement also appears in another language, all required statements must appear in that language too. We can't assess size, contrast, or prominence from text; confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.2" }, { "kind": "format_requirement", "code": "21 CFR 740.10", "title": "Safety-substantiation warning (if applicable)", "what_to_verify": "If your product's safety has not been adequately substantiated, the front panel must bear, word for word: \"Warning\u2014The safety of this product has not been determined.\" We can't tell from the label whether your safety data is on file, confirm whether this applies.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.10" }, { "kind": "format_requirement", "code": "21 CFR 740.19", "title": "Tanning / self-tanner warning (if applicable)", "what_to_verify": "If your product is a suntanning preparation that does not contain a sunscreen, its labeling must display, word for word: \"Warning-This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.\" 21 CFR 740.19 defines \"suntanning preparations\" to include topical products that give a cosmetic effect on the skin while tanning under UV radiation and products that give the appearance of a tan with an approved colour additive such as dihydroxyacetone. We check this automatically when the label names the product as a tanning or self-tanning preparation, or declares dihydroxyacetone. If your product is one and uses wording we did not recognise, confirm this yourself.", "citation_url": "https://www.ecfr.gov/current/title-21/section-740.19" }, { "kind": "format_requirement", "code": "21 CFR 740.11", "title": "Aerosol / pressurized-container warnings (if applicable)", "what_to_verify": "If your product is in a pressurized (aerosol) container, it must bear, word for word: \"Warning\u2014Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 \u00b0F. Keep out of reach of children.\" (Glass: use \"break\" for \"puncture\"; non-spray: omit \"Avoid spraying in eyes\"; children's: add \"except under adult supervision.\") If it uses a halocarbon or hydrocarbon propellant, also: \"Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.\"", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.11" }, { "kind": "format_requirement", "code": "21 CFR 740.2", "title": "Warning-statement conspicuousness (type size, bold, contrast)", "what_to_verify": "Every warning statement must appear prominently and conspicuously compared to other words and designs, in bold type on contrasting background, likely to be read under customary conditions of purchase and use - and never in letters or numbers under 1/16 inch in height (unless FDA has granted a small-package exemption by regulation). We can verify a warning's TEXT is present but not its size, weight, or contrast; confirm these on your packaging artwork.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.2" }, { "kind": "format_requirement", "code": "21 CFR 700.25", "title": "Tamper-resistant packaging for cosmetic liquid oral hygiene and vaginal products (if applicable)", "what_to_verify": "If this product is a cosmetic liquid oral hygiene product or a cosmetic vaginal product, and it is accessible to the public while held for sale, it must be packaged in a tamper-resistant retail package. Except for aerosol products, the retail package must also bear a statement, prominently placed, that alerts consumers to the specific tamper-resistant feature. (An oral-hygiene product marketed with a therapeutic claim is an OTC drug, not a cosmetic, and is covered by 21 CFR 211.132 instead.) A label-text scan cannot verify packaging, so confirm whether this applies to your product.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.25" }, { "kind": "format_requirement", "code": "21 CFR 700.27", "title": "No prohibited cattle (BSE) materials in the formulation (if applicable)", "what_to_verify": "No cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials: specified risk materials, the small intestine of all cattle (unless the distal ileum has been removed by the procedure the regulation specifies), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef. The definition expressly EXCLUDES tallow containing no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, so most common bovine-derived cosmetic ingredients fall outside the ban. If your formula uses any other bovine-derived ingredient, confirm its sourcing with your supplier. A label scan cannot verify ingredient sourcing.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.27" }, { "kind": "format_requirement", "code": "21 CFR 701.3(q); 21 CFR 701.3(i)-(k)", "title": "Ingredient declaration on multiunit and multicomponent packages (if applicable)", "what_to_verify": "21 CFR 701.3(q): the inside containers of a multiunit or multicomponent package need no ingredient declaration when the outer package bears one that meets this section and the inner units are not sold separately. Separately, 701.3(i)-(k) let a package with less than 12 square inches of label surface carry its declaration on a firmly affixed tag, tape or card, or in leaflet labeling on a display unit or chart; such a display unit must carry the words \"Federal law requires ingredient lists to be displayed here\" in letters not less than 3/16 inch high, conspicuous when no lists remain. Not applicable if the individual units' ingredient declarations are already visible through or on the display package. A label-text scan of a single product panel cannot tell whether this product is sold as part of such a display package.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(n)", "title": "\"New ingredient list\" overlabeling notice on formulation changes (if applicable)", "what_to_verify": "21 CFR 701.3(n) is a permission, not a general overlabel duty: when a shortage of a cosmetic ingredient forces a formulation change, packages already printed with the old declaration may still be used if the revised declaration appears either on a firmly affixed tag, tape, card or sticker bearing the conspicuous words \"new ingredient list\" in letters not less than 1/16 inch high, or on labeling inside an unsealed package whose outside bears \"new ingredient list inside\". Not applicable to a label being printed for the first time. A label-text scan cannot tell whether this PDF is such an overlabel.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(1)", "title": "\"May contain\" color additive declaration for batch color-matching (if applicable)", "what_to_verify": "If a color additive is added to only SOME batches of this product for the purpose of color matching, you may declare it using the phrase \"may contain\" (e.g. \"May Contain: Red 33\") instead of listing it as though every batch contains it. This is an OPTIONAL labeling accommodation - a label that lists every color additive unconditionally is also compliant. A label-text scan cannot tell whether a given batch actually varies this way; confirm with your formulator which additives are batch-variable before using this declaration style.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(h)", "title": "Composite color-additive list for an assortment sold in one package (if applicable)", "what_to_verify": "If this product ships as part of an assortment of cosmetics sold together in the same package, you may declare the COLOR ADDITIVES of the whole assortment in a single composite list - instead of a separate color-additive declaration for each product - as long as the listing is not misleading and makes clear it covers every product in the package. This applies to color additives only; the rest of the ingredient declaration follows the ordinary rules. A label-text scan of one product panel cannot tell whether it ships packaged together with others.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(o)", "title": "Cumulative ingredient list for an assortment of similar products (if applicable)", "what_to_verify": "If this product is sold as part of an assortment of products similar in composition and intended for the same use (FDA's example is an eyeshadow palette), you may declare the ingredients common to all of them in a single cumulative list, together with a statement identifying which products contain the other, non-common ingredients - or, if the package's labelable surface is under 12 square inches, in one combined list with no separate non-common statement required. A label-text scan of one product panel cannot tell whether it ships as part of such an assortment.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(2), (o)(3)-(4)", "title": "Shared label declaration for a branded shade line (if applicable)", "what_to_verify": "If this product is one item in a branded shade line sold under a common trade name with no other brand appearing on any item (FDA's examples: one lipstick in a line of lipsticks, or one compact in a line of compacts), the line may share a single label declaring the ingredients common to all shades, plus a statement identifying the other, shade-specific ingredients and which product(s) contain them; shade-specific color additives may use the \"may contain\" declaration under 701.3(g)(2). A label-text scan of one shade's panel cannot tell whether it is part of such a line.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(r)", "title": "Direct-mail alternative ingredient declaration (if applicable)", "what_to_verify": "If this product is sold to consumers by direct mail, the ingredient declaration may appear (letters not less than 1/16 inch high) in the accompanying mailing, sales catalog, or brochure instead of on the package, PROVIDED the mailed package itself carries a notice - visible on opening, letters not less than 3/16 inch high - that states where the declaration is located, promises a copy will be mailed promptly on request, and gives the mail-order distributor's name and place of business; the distributor must then actually fulfill that promise when asked. A label-text scan of the package panel cannot tell whether this product is sold by direct mail or whether the required catalog/brochure declaration exists.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(i)-(k)", "title": "Off-package leaflet ingredient declaration for small/compartmented display units (if applicable)", "what_to_verify": "If this product's package has under 12 square inches of labelable surface (and is not enclosed in an outer carton), the ingredient declaration may instead appear (letters not less than 1/16 inch high) on an accompanying leaflet attached to a compartmented display tray or rack - or, for a shade-matched assortment, attached to a display chart bearing shade samples - rather than on each unit. Strict conditions apply: the leaflet must be visible per specific placement rules (fully readable from the front, or accompanied by a 3/16-inch notice if partially visible or on a side); all copies used with one display must be identical; the unit must ship together with its labeling; the display must show \"Federal law requires ingredient lists to be displayed here\" (3/16 inch minimum) whenever no declaration is currently attached; a formulation change requires the leaflet to be dated and to distinguish old vs. new formula; sufficient copies must be provided for every purchaser; and the firm named on the product must mail a copy to anyone who requests one. A label-text scan of one product's panel cannot tell whether it is sold this way or whether the display unit meets these conditions.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "15 U.S.C. \u00a7 1278a; 16 CFR 1303.2; 16 CFR 1307.2-.3", "title": "CPSIA lead and phthalate limits for children's cosmetics/packaging (if applicable)", "what_to_verify": "If this product, its packaging, or an accessory (e.g. an applicator) is a children's product as defined by the CPSIA, or has any paint or similar surface coating, two federal chemical limits apply: (1) total lead content in any accessible substrate material may not exceed 100 ppm (15 U.S.C. \u00a7 1278a), and lead in paint or similar surface coatings may not exceed 0.009% / 90 ppm (16 CFR 1303.2); (2) a children's toy or child care article may not contain more than 0.1% of any of eight prohibited phthalates - DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP (16 CFR 1307.2-.3) - applying equally to toys and child care articles, no mouth-contact or age distinction. DIDP and DnOP, part of the ORIGINAL 2008 interim ban, are NOT on the current permanent list and are not restricted by this rule today. These are formula/material composition facts a label-text scan cannot see - confirm testing with your supplier if this product is marketed to or usable by children.", "citation_url": "https://www.law.cornell.edu/cfr/text/16/1307.3" }, { "kind": "format_requirement", "code": "19 U.S.C. \u00a7 1304(a)", "title": "Country-of-origin marking for imported product (if applicable)", "what_to_verify": "If this product is of foreign origin, the ARTICLE itself - not merely the shipping carton - must be marked in a conspicuous place, as legibly, indelibly and permanently as the nature of the article will permit, with the English name of the country of origin, for example \"Made in France\". We raise a specific finding automatically only when the label carries a non-US address and we find no origin mark on it. Whether the product is in fact imported, and whether the physical marking is conspicuous, indelible and permanent enough, are facts about the finished package that a label-text scan cannot determine, so confirm both with your manufacturer. If the article is made in the United States, this statute requires no marking.", "citation_url": "https://www.law.cornell.edu/uscode/text/19/1304" } ], "analysis_quality": { "input_source": "pasted", "photo_count": null, "ocr_confidence": null, "claims_confidence": null, "extraction_unverified": false, "ingredient_declaration_readable": true, "claims_screening_incomplete": false, "not_detected_codes": [], "limits": [], "can_certify": true } }, "supplied_facts": [ { "label": "Package amount", "value": "1" }, { "label": "Package unit", "value": "fl oz" }, { "label": "Business name and full address", "value": "Manufactured by Example Beauty, 100 Example St, Austin, TX 78701" }, { "label": "Adverse-event contact", "value": "safety@example.invalid" } ], "changes": [ { "kind": "remove", "text": "Treats eczema and cures acne overnight." }, { "kind": "remove", "text": "Manufactured by Example Beauty, Austin, TX" }, { "kind": "add", "text": "Soothes and improves the look of skin." }, { "kind": "add", "text": "Net Contents 1 fl oz (30 mL)" }, { "kind": "add", "text": "Warnings:" }, { "kind": "add", "text": "Keep out of reach of children." }, { "kind": "add", "text": "Avoid contact with eyes. If contact occurs, rinse thoroughly with water." }, { "kind": "add", "text": "For external use only." }, { "kind": "add", "text": "Discontinue use if irritation or rash occurs." }, { "kind": "add", "text": "Manufactured by Example Beauty, 100 Example St, Austin, TX 78701" }, { "kind": "add", "text": "Questions or adverse event reports: safety@example.invalid" } ], "remaining_checks": [ { "kind": "class_ban_advisory", "code": "advisory.class.PFAS", "title": "PFAS class bans: multiple states (13)", "what_to_verify": "California, Colorado, Connecticut, Illinois, Maine, Minnesota, New Hampshire, New Jersey, New Mexico, Oregon, Rhode Island, Vermont and Washington prohibit or restrict intentionally added PFAS in cosmetics; effective dates vary by state and each state's own finding gives its date. These are class-wide bans, so a label-text scan cannot certify the absence of all PFAS, many are undeclared or appear under trade names. No listed PFAS substance was detected on this label. Confirm with your formulator that no PFAS is intentionally added.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "advisory.class.ortho_phthalate", "title": "Ortho-phthalate class bans: multiple states (3)", "what_to_verify": "Oregon, Vermont and Washington prohibit intentionally added ortho-phthalates in cosmetics; effective dates vary by state and each state's own finding gives its date. This is a class-wide ban and some ortho-phthalates are undisclosed under \"fragrance\", so a label-text scan cannot certify their absence. No phthalate was detected by name on this label. Confirm your formulation contains no intentionally added ortho-phthalates.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "PKG.toxics_in_packaging", "title": "Packaging heavy metals: 100 ppm limit on Pb/Cd/Hg/Cr(VI) in 19 states", "what_to_verify": "Nineteen states have adopted the CONEG/TPCH Toxics in Packaging model law (count per the Toxics in Packaging Clearinghouse fact sheet, rev. Nov 2023). These limit lead, cadmium, mercury and hexavalent chromium in a package or packaging component to 100 parts per million by weight, stated as a combined total in every one of them except Iowa, whose text says only 'the concentration levels'. Five are verified against primary text: Florida (Fla. Stat. 403.7191(3)), Iowa (Iowa Code 455D.19(3)-(4)), Missouri (RSMo 260.822), Pennsylvania (Safe Packaging Act, Act of Dec. 7, 1994, P.L. 797, No. 112, sec. 301), Wisconsin (Wis. Stat. 100.285(2)). Georgia (O.C.G.A. 12-8-162) is included on a secondary reproduction only, not the official code. The 100 ppm tier is in force in all six. NOTE Wisconsin attaches NO PENALTY to its limit (Wis. Stat. 100.285(5)). Only PENNSYLVANIA prohibits INTENTIONAL introduction outright regardless of concentration; Georgia and Iowa carry that clause but gate it on also exceeding the agency-set level, and Florida, Wisconsin and Missouri have no such clause at all. SCOPE: this regulates the PACKAGE, expressly including inks, labels, coatings and closures, NOT the product formula. It therefore cannot be verified or violated by label text, and this scan does not check it.", "citation_url": "https://www.toxicsinpackaging.org" }, { "kind": "class_ban_advisory", "code": "CA.cscp.registration", "title": "California Safe Cosmetics Program: registration may be required", "what_to_verify": "California Safe Cosmetics Program (CSCP): if your company's annual cosmetic sales exceed $1M AND this product contains any chemical on the CDPH Reportable Ingredients List (thousands of chemicals across 22 hazard lists, Prop 65, IARC, NTP, EPA, and EU classifications), you must report it to CDPH at cscpsubmit.cdph.ca.gov. This is a corporate reporting obligation, not an on-label requirement, and it cannot be determined from label text alone, it does not affect whether this label is compliant. Verify your reporting status with CDPH if the revenue threshold applies.", "citation_url": "https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=111792" }, { "kind": "class_ban_advisory", "code": "NY.dioxane_limit", "title": "New York 1,4-dioxane limits (cosmetics 10 ppm; personal care 1 ppm)", "what_to_verify": "New York caps 1,4-dioxane at 10 ppm in cosmetics and 1 ppm in personal care products (ECL Article 37 Title 1, \u00a7 37-0117(3)-(4); 6 NYCRR Subpart 352-1). It is a manufacturing impurity of ethoxylated ingredients (PEGs, -eth- surfactants, polysorbates), never a declared ingredient, so a label scan cannot verify the threshold. If your formula uses ethoxylated ingredients, obtain a 1,4-dioxane test report from your supplier, rinse-off personal care products face the tighter 1 ppm limit.", "citation_url": "https://dec.ny.gov/environmental-protection/pollution-prevention/household-personal-cosmetic-dioxane-limits" }, { "kind": "class_ban_advisory", "code": "MN.heavy_metals_limit", "title": "Minnesota lead and cadmium limits in consumer products", "what_to_verify": "Minnesota caps lead at 90 ppm and cadmium at 75 ppm by total weight in cosmetics and personal care products (Minn. Stat. \u00a7 325E.3892). These are total-content limits, not declared-ingredient limits: colorant and pigment impurities can carry either metal below declaration level. No lead or cadmium compound is declared on this label, but a label scan cannot verify total content - obtain a heavy-metals certificate of analysis from your pigment and raw-material suppliers.", "citation_url": "https://www.revisor.mn.gov/statutes/cite/325E.3892" }, { "kind": "class_ban_advisory", "code": "VT.act131.contaminants", "title": "Vermont Act 131: 1,4-dioxane and asbestos", "what_to_verify": "Vermont Act 131 (9 V.S.A. \u00a72494b, eff. Jan 1, 2026) bans 1,4-dioxane (>=10 ppm) and asbestos. These are typically undeclared contaminants (dioxane an impurity, asbestos a talc contaminant), so a label scan cannot certify their absence and the 10 ppm dioxane threshold is not verifiable from text. Confirm via supplier documentation / testing that 1,4-dioxane is below 10 ppm and no asbestos is present.", "citation_url": "https://legislature.vermont.gov/statutes/section/09/063/02494b" }, { "kind": "class_ban_advisory", "code": "OR.sb546.website_notice", "title": "Oregon manufacturer website notice (operative Jan 1, 2027)", "what_to_verify": "If you manufacture a cosmetic sold or offered for sale in Oregon, review the website-notice duty operative January 1, 2027. ORS 431A.340 applies when the product contains a chemical on OHA's ORS 431A.335 list at or above the applicable de minimis level. Confirm the current OHA list, thresholds and required notice content, including the applicable intentionally added chemical disclosures. This scan does not check your website, concentrations or reporting eligibility.", "citation_url": "https://www.oregonlegislature.gov/bills_laws/ors/ors431a.html" }, { "kind": "class_ban_advisory", "code": "OR.sb546.formaldehyde_releasers", "title": "Oregon SB 546 formaldehyde-releasing agents class ban (takes effect Jan 1, 2027)", "what_to_verify": "Oregon SB 546 formaldehyde-releasing-agent ban (eff. Jan 1, 2027): SB 546 \u00a74 bans this category generically (no statutory list). The scan checks a representative set of common formaldehyde donors; a no-match does not certify absence of every releasing agent. Before Jan 1, 2027 confirm your preservation system releases no formaldehyde (Oregon SB 546, \u00a74).", "citation_url": "https://olis.oregonlegislature.gov/liz/2023R1/Downloads/MeasureDocument/SB546/Enrolled" }, { "kind": "class_ban_advisory", "code": "IH.restricted_preservative.phenoxyethanol", "title": "Phenoxyethanol: flagged for review, not restricted in the US", "what_to_verify": "Phenoxyethanol is on our watch list, but NO US federal or state rule we screen restricts it in cosmetics today, so this is not a violation and nothing on your label has to change because of it. Phenoxyethanol is flagged as a potential hazard (restricted preservative). Widely used cosmetic preservative. EU Annex V Entry 29: maximum 1.0%; no product-type restriction. Japan: 1.0% maximum in cosmetics under MHLW regulation. US: No 21 CFR prohibition. FDA issued a product-specific consumer warning in 2008 concerning Mommy's Bliss Nipple Cream containing phenoxyethanol + chlorphenesin, phenoxyethanol can depress the CNS and cause vomiting and diarrhea in infants via direct nipple-cream exposure. NOT a general FDA advisory on phenoxyethanol. Not Prop 65 listed. Flagged under some clean beauty retailer standards. Raise it with your formulator if the concern matters for your product or your retailer's own standards.", "citation_url": null }, { "kind": "class_ban_advisory", "code": "AMZ.unit_coding", "title": "Lot code and expiration or period-after-opening marking (Amazon)", "what_to_verify": "Amazon's cosmetics listing requirements ask that units display identifying codes such as lot or serial numbers, and an expiration date for products with a shelf life under three years or otherwise a period-after-opening symbol such as '12M'. A lot code is usually a fill-line inkjet or laser mark and the PAO symbol is a pictogram, so neither can be verified from label text; this note appears on every Amazon check rather than reporting a false absence. Amazon's own cosmetics help page is behind a Seller Central sign-in.", "citation_url": null }, { "kind": "format_requirement", "code": "21 U.S.C. \u00a7 364e(c) (FD&C Act \u00a7 609)", "title": "Professional-use-only products must state they are for use only by licensed professionals", "what_to_verify": "If this product is distributed for use only by professionals, add a clear, prominent statement that it is to be used only by licensed professionals (cosmetology, nail care, barbering, or esthetics). A label scan cannot certify whether a product is professional-distribution-only, so confirm this applies to your product.", "citation_url": "https://uscode.house.gov/view.xhtml?req=(title:21%20section:364e%20edition:prelim)" }, { "kind": "format_requirement", "code": "21 CFR 701.13(e), (f), (i)", "title": "Net quantity placement and lettering size", "what_to_verify": "Put the net quantity on the front (principal display) panel, in the bottom 30% of that panel, parallel to the base. The bottom-30% placement requirement does not apply to panels of 5 square inches or less when the other requirements are met. Minimum letter height by panel size: 1/16\" (\u22645 sq in), 1/8\" (>5, 25), 3/16\" (>25, 100), 1/4\" (>100 up to 400), 1/2\" (>400). Add 1/16\" if lettering is blown, embossed, or molded. We can't measure panel size or lettering from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.13(f)", "title": "Clear space around the net quantity statement", "what_to_verify": "Separate the net quantity from other printed label information above and below by at least the height of its lettering. Leave at least twice the width of its letter N to the left and right. Confirm this on the print artwork; the current PDF checks do not measure this clearance.", "citation_url": "https://www.ecfr.gov/current/title-21/section-701.13" }, { "kind": "format_requirement", "code": "21 CFR 701.11", "title": "Statement of identity prominence and placement", "what_to_verify": "Show what the product is (common name, descriptive name, or an illustration) on the front panel as one of its main features, in bold type, sized in proportion to the most prominent text on that panel. We can't verify size or panel position from text, confirm this on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.11" }, { "kind": "format_requirement", "code": "21 CFR 701.3(a), (f)", "title": "Ingredients in descending order of predominance", "what_to_verify": "List ingredients from most to least by amount. Exception: ingredients at 1% or less may appear in any order after those above 1%, and color additives may appear in any order at the end. We can't see your formula's concentrations from the label, so we can't verify the order, confirm it matches your formulation.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3", "title": "Ingredient lettering size / small-package options", "what_to_verify": "Ingredient lettering must meet the minimum height for your package size. Very small packages may place the ingredient list on a tag, tape, or card firmly affixed to the package, or on accompanying display material. We can't measure this from text, confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3, 701.12, 701.13(e)", "title": "Correct panel placement (front panel vs. information panel)", "what_to_verify": "Net quantity goes on the front (principal display) panel; the ingredient list and the manufacturer/distributor name and address may go on an information panel. We check that this information is present in your text but can't tell which physical panel it's on, confirm panel placement on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.12" }, { "kind": "format_requirement", "code": "21 CFR 701.2", "title": "Conspicuousness, contrast, and English", "what_to_verify": "All required statements must be in English and easy to find and read under normal shopping conditions, adequate type size, good contrast, not crowded. If any required statement also appears in another language, all required statements must appear in that language too. We can't assess size, contrast, or prominence from text; confirm on your packaging.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.2" }, { "kind": "format_requirement", "code": "21 CFR 740.10", "title": "Safety-substantiation warning (if applicable)", "what_to_verify": "If your product's safety has not been adequately substantiated, the front panel must bear, word for word: \"Warning\u2014The safety of this product has not been determined.\" We can't tell from the label whether your safety data is on file, confirm whether this applies.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.10" }, { "kind": "format_requirement", "code": "21 CFR 740.19", "title": "Tanning / self-tanner warning (if applicable)", "what_to_verify": "If your product is a suntanning preparation that does not contain a sunscreen, its labeling must display, word for word: \"Warning-This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.\" 21 CFR 740.19 defines \"suntanning preparations\" to include topical products that give a cosmetic effect on the skin while tanning under UV radiation and products that give the appearance of a tan with an approved colour additive such as dihydroxyacetone. We check this automatically when the label names the product as a tanning or self-tanning preparation, or declares dihydroxyacetone. If your product is one and uses wording we did not recognise, confirm this yourself.", "citation_url": "https://www.ecfr.gov/current/title-21/section-740.19" }, { "kind": "format_requirement", "code": "21 CFR 740.11", "title": "Aerosol / pressurized-container warnings (if applicable)", "what_to_verify": "If your product is in a pressurized (aerosol) container, it must bear, word for word: \"Warning\u2014Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 \u00b0F. Keep out of reach of children.\" (Glass: use \"break\" for \"puncture\"; non-spray: omit \"Avoid spraying in eyes\"; children's: add \"except under adult supervision.\") If it uses a halocarbon or hydrocarbon propellant, also: \"Warning-Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.\"", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.11" }, { "kind": "format_requirement", "code": "21 CFR 740.2", "title": "Warning-statement conspicuousness (type size, bold, contrast)", "what_to_verify": "Every warning statement must appear prominently and conspicuously compared to other words and designs, in bold type on contrasting background, likely to be read under customary conditions of purchase and use - and never in letters or numbers under 1/16 inch in height (unless FDA has granted a small-package exemption by regulation). We can verify a warning's TEXT is present but not its size, weight, or contrast; confirm these on your packaging artwork.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/740.2" }, { "kind": "format_requirement", "code": "21 CFR 700.25", "title": "Tamper-resistant packaging for cosmetic liquid oral hygiene and vaginal products (if applicable)", "what_to_verify": "If this product is a cosmetic liquid oral hygiene product or a cosmetic vaginal product, and it is accessible to the public while held for sale, it must be packaged in a tamper-resistant retail package. Except for aerosol products, the retail package must also bear a statement, prominently placed, that alerts consumers to the specific tamper-resistant feature. (An oral-hygiene product marketed with a therapeutic claim is an OTC drug, not a cosmetic, and is covered by 21 CFR 211.132 instead.) A label-text scan cannot verify packaging, so confirm whether this applies to your product.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.25" }, { "kind": "format_requirement", "code": "21 CFR 700.27", "title": "No prohibited cattle (BSE) materials in the formulation (if applicable)", "what_to_verify": "No cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials: specified risk materials, the small intestine of all cattle (unless the distal ileum has been removed by the procedure the regulation specifies), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated beef. The definition expressly EXCLUDES tallow containing no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, so most common bovine-derived cosmetic ingredients fall outside the ban. If your formula uses any other bovine-derived ingredient, confirm its sourcing with your supplier. A label scan cannot verify ingredient sourcing.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/700.27" }, { "kind": "format_requirement", "code": "21 CFR 701.3(q); 21 CFR 701.3(i)-(k)", "title": "Ingredient declaration on multiunit and multicomponent packages (if applicable)", "what_to_verify": "21 CFR 701.3(q): the inside containers of a multiunit or multicomponent package need no ingredient declaration when the outer package bears one that meets this section and the inner units are not sold separately. Separately, 701.3(i)-(k) let a package with less than 12 square inches of label surface carry its declaration on a firmly affixed tag, tape or card, or in leaflet labeling on a display unit or chart; such a display unit must carry the words \"Federal law requires ingredient lists to be displayed here\" in letters not less than 3/16 inch high, conspicuous when no lists remain. Not applicable if the individual units' ingredient declarations are already visible through or on the display package. A label-text scan of a single product panel cannot tell whether this product is sold as part of such a display package.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(n)", "title": "\"New ingredient list\" overlabeling notice on formulation changes (if applicable)", "what_to_verify": "21 CFR 701.3(n) is a permission, not a general overlabel duty: when a shortage of a cosmetic ingredient forces a formulation change, packages already printed with the old declaration may still be used if the revised declaration appears either on a firmly affixed tag, tape, card or sticker bearing the conspicuous words \"new ingredient list\" in letters not less than 1/16 inch high, or on labeling inside an unsealed package whose outside bears \"new ingredient list inside\". Not applicable to a label being printed for the first time. A label-text scan cannot tell whether this PDF is such an overlabel.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(1)", "title": "\"May contain\" color additive declaration for batch color-matching (if applicable)", "what_to_verify": "If a color additive is added to only SOME batches of this product for the purpose of color matching, you may declare it using the phrase \"may contain\" (e.g. \"May Contain: Red 33\") instead of listing it as though every batch contains it. This is an OPTIONAL labeling accommodation - a label that lists every color additive unconditionally is also compliant. A label-text scan cannot tell whether a given batch actually varies this way; confirm with your formulator which additives are batch-variable before using this declaration style.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(h)", "title": "Composite color-additive list for an assortment sold in one package (if applicable)", "what_to_verify": "If this product ships as part of an assortment of cosmetics sold together in the same package, you may declare the COLOR ADDITIVES of the whole assortment in a single composite list - instead of a separate color-additive declaration for each product - as long as the listing is not misleading and makes clear it covers every product in the package. This applies to color additives only; the rest of the ingredient declaration follows the ordinary rules. A label-text scan of one product panel cannot tell whether it ships packaged together with others.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(o)", "title": "Cumulative ingredient list for an assortment of similar products (if applicable)", "what_to_verify": "If this product is sold as part of an assortment of products similar in composition and intended for the same use (FDA's example is an eyeshadow palette), you may declare the ingredients common to all of them in a single cumulative list, together with a statement identifying which products contain the other, non-common ingredients - or, if the package's labelable surface is under 12 square inches, in one combined list with no separate non-common statement required. A label-text scan of one product panel cannot tell whether it ships as part of such an assortment.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(g)(2), (o)(3)-(4)", "title": "Shared label declaration for a branded shade line (if applicable)", "what_to_verify": "If this product is one item in a branded shade line sold under a common trade name with no other brand appearing on any item (FDA's examples: one lipstick in a line of lipsticks, or one compact in a line of compacts), the line may share a single label declaring the ingredients common to all shades, plus a statement identifying the other, shade-specific ingredients and which product(s) contain them; shade-specific color additives may use the \"may contain\" declaration under 701.3(g)(2). A label-text scan of one shade's panel cannot tell whether it is part of such a line.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(r)", "title": "Direct-mail alternative ingredient declaration (if applicable)", "what_to_verify": "If this product is sold to consumers by direct mail, the ingredient declaration may appear (letters not less than 1/16 inch high) in the accompanying mailing, sales catalog, or brochure instead of on the package, PROVIDED the mailed package itself carries a notice - visible on opening, letters not less than 3/16 inch high - that states where the declaration is located, promises a copy will be mailed promptly on request, and gives the mail-order distributor's name and place of business; the distributor must then actually fulfill that promise when asked. A label-text scan of the package panel cannot tell whether this product is sold by direct mail or whether the required catalog/brochure declaration exists.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "21 CFR 701.3(i)-(k)", "title": "Off-package leaflet ingredient declaration for small/compartmented display units (if applicable)", "what_to_verify": "If this product's package has under 12 square inches of labelable surface (and is not enclosed in an outer carton), the ingredient declaration may instead appear (letters not less than 1/16 inch high) on an accompanying leaflet attached to a compartmented display tray or rack - or, for a shade-matched assortment, attached to a display chart bearing shade samples - rather than on each unit. Strict conditions apply: the leaflet must be visible per specific placement rules (fully readable from the front, or accompanied by a 3/16-inch notice if partially visible or on a side); all copies used with one display must be identical; the unit must ship together with its labeling; the display must show \"Federal law requires ingredient lists to be displayed here\" (3/16 inch minimum) whenever no declaration is currently attached; a formulation change requires the leaflet to be dated and to distinguish old vs. new formula; sufficient copies must be provided for every purchaser; and the firm named on the product must mail a copy to anyone who requests one. A label-text scan of one product's panel cannot tell whether it is sold this way or whether the display unit meets these conditions.", "citation_url": "https://www.law.cornell.edu/cfr/text/21/701.3" }, { "kind": "format_requirement", "code": "15 U.S.C. \u00a7 1278a; 16 CFR 1303.2; 16 CFR 1307.2-.3", "title": "CPSIA lead and phthalate limits for children's cosmetics/packaging (if applicable)", "what_to_verify": "If this product, its packaging, or an accessory (e.g. an applicator) is a children's product as defined by the CPSIA, or has any paint or similar surface coating, two federal chemical limits apply: (1) total lead content in any accessible substrate material may not exceed 100 ppm (15 U.S.C. \u00a7 1278a), and lead in paint or similar surface coatings may not exceed 0.009% / 90 ppm (16 CFR 1303.2); (2) a children's toy or child care article may not contain more than 0.1% of any of eight prohibited phthalates - DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP (16 CFR 1307.2-.3) - applying equally to toys and child care articles, no mouth-contact or age distinction. DIDP and DnOP, part of the ORIGINAL 2008 interim ban, are NOT on the current permanent list and are not restricted by this rule today. These are formula/material composition facts a label-text scan cannot see - confirm testing with your supplier if this product is marketed to or usable by children.", "citation_url": "https://www.law.cornell.edu/cfr/text/16/1307.3" }, { "kind": "format_requirement", "code": "19 U.S.C. \u00a7 1304(a)", "title": "Country-of-origin marking for imported product (if applicable)", "what_to_verify": "If this product is of foreign origin, the ARTICLE itself - not merely the shipping carton - must be marked in a conspicuous place, as legibly, indelibly and permanently as the nature of the article will permit, with the English name of the country of origin, for example \"Made in France\". We raise a specific finding automatically only when the label carries a non-US address and we find no origin mark on it. Whether the product is in fact imported, and whether the physical marking is conspicuous, indelible and permanent enough, are facts about the finished package that a label-text scan cannot determine, so confirm both with your manufacturer. If the article is made in the United States, this statute requires no marking.", "citation_url": "https://www.law.cornell.edu/uscode/text/19/1304" } ], "artwork": { "status": "not_assessed", "reason": "No print PDF was analyzed." }, "files": { "retailer-report.pdf": { "title": "Retailer report", "sha256": "12679014a95791723738faa2840c493233fff161e238740e67cdfd516f3ebdda", "fixture_version": "radiance-7712b99260dc", "scan_id": 2, "label_id": 1, "version_number": 2 }, "attorney-report.pdf": { "title": "Attorney report", "sha256": "acb9266b6f29afce1f2b6c0744932021d576f4bb2203114138469cc1005b2e33", "fixture_version": "radiance-7712b99260dc", "scan_id": 2, "label_id": 1, "version_number": 2 }, "corrected-label.pdf": { "title": "Corrected label PDF", "sha256": "c9b48b28643cf33884a136914edff6bef3967458c36caceb09339ecb5924ee01", "fixture_version": "radiance-7712b99260dc", "scan_id": 2, "label_id": 1, "version_number": 2 } }, "provenance": { "method": "Real /scan responses, shipped Apply All Fixes functions, real report routes; isolated fictional fixture.", "frontend_sha256": "9c567f90d2efe8773425acae9d75ed2624ffe8e914ab99b3882b1bd2d1154cd0", "corrected_text_sha256": "468f2b0dd868e721cde8c8d918ea73e3b3f8c346e6b738bb7f845a9434e7831b", "report_scan_id": 2, "report_label_id": 1, "report_version_number": 2 }, "fixture_version": "radiance-7712b99260dc" }