Does a barrier cream with zinc oxide need FDA approval?

If your barrier cream contains zinc oxide and makes drug claims — such as treating diaper rash, minor burns, or chapped skin — it may be regulated as an OTC drug under FDA's monograph system, not as a cosmetic. This requires cGMP manufacturing under 21 CFR Part 211 and specific labeling. A qualified cosmetic chemist found through AJ Cosmo Labs can help you determine the correct regulatory path before you invest in production.