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Canned Food Arrangement

FDA Registration for OTC Drugs & Sunscreens — Monograph Compliance Done Right

Sunscreens, sanitizers, topicals, and other OTC monograph drugs don't need FDA pre-approval — but they do need everything else: an FDA-registered establishment, drug listing with an NDC, a validated SPL, and a compliant Drug Facts label that matches the monograph. Foreign makers also need a U.S. Agent. Axentra runs the whole stack.

What "monograph compliance" means

Your formula must fit the applicable OTC monograph (e.g., sunscreen actives and doses under 21 CFR 352 / OTC Monograph M020), your label must follow Drug Facts format (21 CFR 201.66), your facility registers annually, and every product is listed with FDA via SPL with June annual certification (21 CFR Part 207).

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