Drug-Cosmetic Boundary Product Compliance Audit

Inspection template for auditing SPF, medicated skincare, and anti-dandruff SKUs against drug-versus-cosmetic claim classification, labeling, and product presentation requirements.

Audit Scope and SKU Identification

• SKU, product name, and variant match the approved audit scope
• Product category is correctly identified as sunscreen/SPF, medicated skincare, anti-dandruff, or other boundary product
• Market/country and label version reviewed are documented
• Primary label, secondary panel, and outer carton are available for review

Drug Versus Cosmetic Claim Classification

• Front-of-pack and marketing claims are consistent with the product's intended classification
• No unapproved therapeutic claims are present
  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.
• SPF claims are limited to permitted sunscreen language and are not overstated
  Verify SPF value, broad spectrum statements, water resistance claims, and any usage directions are consistent with the approved label and applicable sunscreen requirements.
• Anti-dandruff or medicated skincare claims are supported by the active ingredient and product labeling
• Claims do not imply a drug effect through imagery, testimonials, or before-and-after presentation

Label Content and Required Statements

• Required product identity statement is present and accurate
• Active ingredient declaration is present where required and matches the approved formula
• Drug Facts panel is present and legible when the product is regulated as an OTC drug
• Inactive ingredient list uses consistent ingredient naming and is complete
• Warnings, directions, and usage limitations are present and readable

Ingredient and Formula Verification

• Declared active ingredient matches the approved formula and concentration
• Ingredient nomenclature is consistent with the approved ingredient list and INCI-style naming where applicable
• No undeclared or conflicting ingredients are indicated on any reviewed panel
• Any fragrance, color additive, or preservative disclosures are consistent across label panels

Packaging, Presentation, and Compliance Evidence

• Package graphics, icons, seals, and badges do not imply unsupported drug efficacy
• Batch/lot code and expiration or best-by date are present when required
• Inspector captured clear photos of the front panel, ingredient panel, and any Drug Facts or caution statement panels
• Corrective action or escalation is documented for any non-conformance