Run Drug-Cosmetic Boundary Product Compliance Audit — Free

Audit Scope and SKU Identification

SKU, product name, and variant match the approved audit scope critical (required)

Product category is correctly identified as sunscreen/SPF, medicated skincare, anti-dandruff, or other boundary product critical (required)

Market/country and label version reviewed are documented critical (required)

Primary label, secondary panel, and outer carton are available for review critical (required)

Yes No N/A

Drug Versus Cosmetic Claim Classification

Front-of-pack and marketing claims are consistent with the product's intended classification critical (required)

Yes No N/A

Photo evidence (optional)

No unapproved therapeutic claims are present critical (required)

Check for claims such as 'treats', 'cures', 'prevents', 'heals', 'antibacterial', 'anti-inflammatory', or similar drug claims unless supported by the approved product category and labeling.

Yes No N/A

Photo evidence (optional)

SPF claims are limited to permitted sunscreen language and are not overstated critical (required)

Verify SPF value, broad spectrum statements, water resistance claims, and any usage directions are consistent with the approved label and applicable sunscreen requirements.

Yes No N/A

Photo evidence (optional)

Anti-dandruff or medicated skincare claims are supported by the active ingredient and product labeling critical (required)

Yes No N/A

Photo evidence (optional)

Claims do not imply a drug effect through imagery, testimonials, or before-and-after presentation

Yes No N/A

Photo evidence (optional)

Label Content and Required Statements

Required product identity statement is present and accurate critical (required)

Yes No N/A

Photo evidence (optional)

Active ingredient declaration is present where required and matches the approved formula critical (required)

Yes No N/A

Photo evidence (optional)

Drug Facts panel is present and legible when the product is regulated as an OTC drug critical (required)

Yes No N/A

Photo evidence (optional)

Inactive ingredient list uses consistent ingredient naming and is complete critical (required)

Yes No N/A

Photo evidence (optional)

Warnings, directions, and usage limitations are present and readable critical (required)

Yes No N/A

Photo evidence (optional)

Ingredient and Formula Verification

Declared active ingredient matches the approved formula and concentration critical (required)

Ingredient nomenclature is consistent with the approved ingredient list and INCI-style naming where applicable critical (required)

Yes No N/A

Photo evidence (optional)

No undeclared or conflicting ingredients are indicated on any reviewed panel critical (required)

Yes No N/A

Photo evidence (optional)

Any fragrance, color additive, or preservative disclosures are consistent across label panels

Yes No N/A

Photo evidence (optional)

Packaging, Presentation, and Compliance Evidence

Package graphics, icons, seals, and badges do not imply unsupported drug efficacy critical (required)

Yes No N/A

Photo evidence (optional)

Batch/lot code and expiration or best-by date are present when required

Yes No N/A

Photo evidence (optional)

Inspector captured clear photos of the front panel, ingredient panel, and any Drug Facts or caution statement panels critical (required)

Yes No N/A

Corrective action or escalation is documented for any non-conformance critical (required)

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Run: Drug-Cosmetic Boundary Product Compliance Audit

Audit Scope and SKU Identification

Drug Versus Cosmetic Claim Classification

Label Content and Required Statements

Ingredient and Formula Verification

Packaging, Presentation, and Compliance Evidence

Get your results