Buyer questions · Purchase decisions
Sunscreen is regulated as an OTC drug in the United States: what must the OEM factory hold, how is SPF tested, and what goes on the label?
Sunscreens containing SPF actives are regulated as OTC drugs in the U. S. , not cosmetics. Facility GMP must meet pharmaceutical standards under the FD&C Act rather than cosmetics GMP alone. SPF is tested per OTC monograph methods (in vitro and in vivo human SPF protocols). Labels must use the mandatory 'Drug Facts' panel format with the NDC code, active ingredients, SPF claim, and usage directions, not standard cosmetics labeling.
1Facility qualifications and documentation
As an OTC drug, the facility must register and list under the FDA drug system, not the Cosmetics Direct portal. Production must comply with 21 CFR Part 211 cGMP. The 'Responsible Person' on the label must be the manufacturer, packer, or distributor with a US address, and a US Agent is required for adverse event reporting.
2SPF testing and safety substantiation
SPF claims must be substantiated per OTC monograph methods, typically involving in vivo human SPF testing and in vitro UVA measurement. Formulators must prepare comprehensive safety substantiation records, including heavy metals, microbial challenge, and stability data, as required for post-market review.
3Label design and compliance warnings
Labels must feature the 'Drug Facts' panel listing Active Ingredients, Inactive Ingredients, Directions, and Warnings. The NDC code must be clearly visible. Statements such as 'FDA Approved' or 'FDA Certified' are strictly prohibited and constitute false advertising.
Follow-up questions
- Q:Can we make a day cream without SPF claims to avoid drug regulation?
- A:Yes, but you must remove all SPF numbers and actives; otherwise, it remains an OTC drug.
- Q:Is sunscreen treated as a drug in Canada too?
- A:Yes, it generally requires a DIN/NPN as a natural health product or drug, separate from the US system.
Figures sourced from:各国法规 · 美国美国防晒代工FDA 化妆品禁用与限用成分、色素添加剂配方库
Updated 2026-09-18
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