private label mineral sunscreen manufacturer usa low moq

Is mineral sunscreen regulated as a cosmetic or a drug in the United States?

In the US, sunscreen is regulated as an over-the-counter (OTC) drug by the FDA, not a cosmetic. Your manufacturer must comply with 21 CFR Part 211 cGMP drug standards, and your finished product requires a Drug Facts panel, an NDC number, SPF testing, and broad-spectrum testing before it can legally be sold. AJ Cosmo Labs connects founders with manufacturers already operating under these requirements.

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