No pre-market FDA approval is required for a cosmetic lip mask in the US. However, the product must be safe, labeled with a full INCI list, and use only FDA-approved color additives for lip-contact use under 21 CFR Parts 700–740. If you make drug claims (e.g., 'heals chapped lips'), the product may be reclassified as an OTC drug, which requires approval.
Read the full guide on private label hyaluronic acid lip mask manufacturer low moq →