US Market Entry: Ingredients & Restrictions
The United States does not keep a single positive list of permitted cosmetic ingredients in the way the EU does. Restrictions arrive through several routes instead: named prohibitions and restrictions, colour additive certification, and the OTC monograph where a product is treated as a drug.
At a glance
- Positive lists
- None for general cosmetic ingredients
- Colour additives
- Certification required for many, with a narrower set near the eye
- Prohibited substances
- Named bans and restrictions rather than one annex
- Drug actives
- Must match the relevant OTC monograph
What the market requires
Colour additives
Many colour additives used in cosmetics must come from a certified batch, and the permitted set is narrower for products applied near the eye than for other cosmetics. Using an uncertified lake is a compliance failure rather than a shade variation.
Prohibited and restricted substances
US restrictions sit across statutes and FDA rules rather than in one annex, covering named substances and, for some, concentration or use conditions. A formulator working to EU rules still has to check the US position separately.
Sunscreen actives
A sunscreen sold in the US must use actives permitted by the OTC monograph at permitted concentrations. Filters widely used elsewhere may not be available, which is why a US sunscreen often differs from the same brand's European product.
What this means for your brief
Market-specific ingredient screening is cheaper before formulation than after. If a US launch is in your plan, screen the proposed actives and colourants while the formula is still a draft rather than after artwork approval.
What we provide
- Ingredient declarations and full formula documentation for your market screening
- Colourant and active sourcing that reflects the destination market's permitted options
- Stability and microbiology data on the actives actually used, not on a substituted equivalent
Capabilities above are limited to what is verifiable: GMPC and ISO 22716 certification audited by third parties, cosmetics production licence 粤妆20250206, and FDA MoCRA facility registration. See certifications.
Market questions
Is an EU-compliant formula automatically US-compliant?
No. The two systems restrict different things in different ways. Sunscreen actives are the clearest example, because the permitted list differs, so brands often sell different formulas per market.
Can one formula serve both markets?
Often, but not automatically. It has to be screened against both sets of restrictions, and colourants and sunscreen actives are the usual points of divergence.
More on United States market entry
Regulatory requirements change. Confirm the current position for your product with your local adviser or appointed representative before you place artwork or place an order. See also certifications and compliance and the sourcing glossary.
Sourcing for United States?
Send your product brief with the destination market — quotation and formula recommendations within 24 hours.
Get a Free Quote