Glossary · Regulation & Compliance
What Is OTC Monograph (US Sunscreen)?
In the United States, sunscreen is regulated as an over-the-counter drug, and the FDA's OTC sunscreen monograph defines the permitted active ingredients, maximum concentrations, the SPF and broad-spectrum test methods and the required labelling. A sunscreen sold in the US must fit the monograph rather than the cosmetics framework.
Why it matters when you source
This single classification decides your testing budget, your label and your factory's documentation set: SPF and broad-spectrum results, a drug facts panel, and active ingredients that meet the monograph. Confirm the regulatory route before you brief a texture.
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