Buyer questions · Purchase decisions
Selling cosmetics in the US after MoCRA: what is actually required, and does the FDA approve products?
The FDA does not approve cosmetics. MoCRA makes three things mandatory: facility registration, product listing, and a US agent with adverse-event records. There is no positive ingredient list, only prohibitions and the colour-additive regulations (21 CFR 73/74/82). Sunscreen is the exception: it is an OTC drug.
1Facility registration and product listing
Facilities register in FDA Cosmetics Direct and renew every two years; each marketed SKU is listed and updated on reformulation. The responsible person (usually the brand) files; the factory supplies facility and formula information.
2Safety substantiation and labelling
MoCRA requires safety substantiation records, largely the same evidence as an EU PIF. Labels need a US contact address and INCI in descending order; fragrance-allergen labelling follows once the FDA rule is final.
3Sunscreen is a drug
SPF products follow the OTC monograph (21 CFR 352): only listed filters at listed levels, SPF and broad-spectrum testing, and drug GMP at the facility. Most newer Asian UV filters are not permitted in the US.
Follow-up questions
- Q:Are small businesses exempt?
- A:Below a revenue threshold, facility registration and listing are waived, with exceptions for eye-area and similar categories; check the current FDA guidance.
- Q:Can Canada be covered in the same pass?
- A:Not as-is: Canada's Hotlist (653 entries on site) is more granular than the US list and needs its own check.
Figures sourced from:美国 FDA 禁限用与色素加拿大 Hotlist各国备案索引
Updated 2026-09-16
Want this worked out for your category and target market? Send an inquiry