Do private label moisturizers need FDA approval before selling in the US?

Cosmetic moisturizers sold in the US do not require pre-market FDA approval, but they must comply with 21 CFR labeling rules — correct INCI ingredient list, net weight, manufacturer address, and no unapproved drug claims. If you add SPF, the product becomes an OTC drug and requires FDA monograph compliance. AJ Cosmo Labs connects you with manufacturers experienced in US regulatory requirements.