SPF lip balm is classified as an OTC drug-cosmetic combination product in the US. The FDA requires a Drug Facts panel, use of monograph-approved active ingredients (e.g., Zinc Oxide, Octinoxate), and production in a cGMP-compliant OTC drug facility. Your manufacturer must be FDA-registered as a drug establishment. AJ Cosmo Labs lets you filter for OTC-certified facilities so you stay compliant from day one.
Read the full guide on private label spf lip balm manufacturer usa low moq →