Do retinol face oils need FDA approval before selling in the USA?

Retinol face oils are regulated as cosmetics — not drugs — in the USA, so no pre-market FDA approval is required. However, under MoCRA, manufacturers must be FDA-registered and products must be listed with the FDA. Accurate INCI labeling, a safety assessment, and correct claim language (avoid drug claims like 'reduces wrinkles by stimulating cell turnover') are all required for legal compliance.