Cosmetics & Skincare Product Compliance Manager

Key facts

• Price: $29/mo
• Category: business
• Environment: ironclaw
• Tags: cosmetics, skincare, beauty, fda, mocra, eu-compliance
• Seller: ClawHQ

What it does

Selling skincare or cosmetics in the U.S. and EU means navigating FDA cosmetic regulations, MoCRA (Modernization of Cosmetics Regulation Act) facility registration, EU Cosmetics Regulation 1223/2009, CPNP notification, INCI naming, allergen labeling, and the regulatory minefield that separates "compliant" from "the FDA pulls your Shopify listing." This compliance manager keeps your formulations, labels, and documentation audit-ready across U.S. + EU + UK + Canada in one conversational interface. ## What's included - **Ingredient compliance checker** — paste an INCI list, get U.S. + EU + UK + Canada regulatory status per ingredient: allowed, restricted (with max %), banned, requires warning label, allergen disclosure trigger - **MoCRA registration assistant (U.S.)** — facility + product listing requirements, responsible-person assignment, adverse-event recordkeeping; flags the 2024+ enforcement triggers - **EU CPNP notification prep** — Cosmetic Product Notification Portal data assembly: composition, frangrance allergens, nanomaterial disclosure, RP assignment - **Label generator (U.S. + EU compliant)** — front panel + ingredient declaration in correct order, country-of-origin, RP address, batch/lot number format, net weight in correct units, allergen highlighting (26 EU allergens, current FDA list) - **Claims compliance review** — paste your marketing copy; flags "drug claims" that reclassify a cosmetic as an unapproved drug ("anti-aging" vs "minimizes appearance of fine lines"), unsupported clinical claims, banned terms - **Stability + PIF (Product Information File) checklist** — what your CPSR / safety assessor needs, batch testing records, GMP documentation - **Allergen + fragrance disclosure** — current EU 26-allergen list + emerging 56-allergen update; flags when fragrance composition triggers labeling - **Country-specific quirks** — Canada Hotlist, UK post-Brexit divergence, California Prop 65 warnings, Washington Cosmetic Safety Act, FDA color additive certification - **Recall + adverse event protocols** — MoCRA serious adverse event 15-day reporting timeline, EU undesirable effect reporting, draft response templates ## Limitations - **NOT a CPSR safety assessor** — flags issues for your qualified safety assessor; the formal Cosmetic Product Safety Report still needs a credentialed toxicologist - **NOT legal counsel** — surfaces regulatory risk + drafts documentation; FDA warning letter responses + enforcement actions need a regulatory attorney - **NOT a lab** — doesn't run microbial, stability, or challenge testing; pairs with your contract lab - **Major markets covered** — U.S., EU-27, UK, Canada; AU/JP/KR/CN are starter-only (each has distinct ingredient + labeling regimes) - **Cosmetics scope** — does not handle OTC drugs (sunscreens with SPF claims in U.S., acne treatments) which require separate FDA monograph compliance ## Best fit Indie skincare + cosmetic founders selling DTC on Shopify, Amazon, retail. Brands hitting $100K-$5M revenue where you're past hobby but not yet hiring a regulatory specialist. Especially valuable for brands expanding U.S. → EU or adding ingredients (peptides, retinol derivatives, exotic actives) where the regulatory status differs by jurisdiction. At $29/mo, catching ONE banned-ingredient ship-block or claims violation pays for years.