SPF 50 Sunscreen — Failed the Drug/Cosmetic Dual Regulation
No Drug Facts Box
Situation
A Korean cosmetics brand exported an SPF 50 sunscreen to the U.S. The ingredient list was accurate, but the team overlooked that sunscreen is regulated as both a cosmetic and an OTC drug, and left out the Drug Facts box.
Problem
Products claiming SPF must carry, under FDA's OTC Monograph (21 CFR Part 352), an additional Active Ingredient listing (e.g., Zinc Oxide 20%) and a Drug Facts box — leaving these out results in misbranding.
Timeline
- Day 1 — arrival, FDA label inspection
- Day 7 — missing Drug Facts box and Active Ingredient labeling flagged
- Day 21 — label rework plan submitted, conditional clearance granted, correction mandatory starting with the next lot
Losses
3 weeks of storageLabel rework cost
📌 Any product with an SPF number is subject to dual drug/cosmetic regulation. Cosmetic labeling rules alone aren't enough.