Yes. Color additives used in cosmetics sold in the US must be approved by FDA and, for certain uses (particularly eye-area cosmetics and ingested products like lip color), must be from a batch certified by FDA. Cosmetics containing unapproved or uncertified color additives are considered adulterated and can be refused entry or subject to recall.

The EU Cosmetics Regulation prohibits or restricts over a thousand ingredients, while the US currently restricts far fewer under the FD&C Act. This means a product legally formulated and sold in the EU may still contain ingredients that are restricted or require specific labeling in the US — or conversely, a US-compliant formula may not meet EU standards. Importers sourcing finished cosmetics from European manufacturers should conduct a US-specific ingredient review rather than assuming EU compliance translates directly.