If it contains an FDA-recognized anti-acne active — salicylic acid (0.5–2%), benzoyl peroxide (2.5–10%), or sulfur (3–10%) — the product is regulated as an OTC drug under 21 CFR Part 333, not a cosmetic. Your cosmetic chemist must understand monograph compliance, labeling drug facts panels, and cGMP manufacturing requirements for OTC products.
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