Drug vs. Cosmetic: Why US Sunscreen Rules Differ From Korea and Europe
The reason foreign sunscreens can't just appear on US shelves comes down to one word: drug.
The US FDA classifies sunscreens as over-the-counter drugs requiring GRASE drug approval, while the EU, Japan and South Korea regulate them as cosmetics or 'functional cosmetics,' enabling far faster filter approvals.
Regulatory analysts explain that because the US treats UV filters as drugs subject to the GRASE standard, new filters face a long, data-intensive approval path, whereas Korea's 'functional cosmetic' framework lets manufacturers bring novel filters to market much more quickly.
Questions we get a lot
Why does the US regulate sunscreen as a drug?
Because sunscreens make a protection claim, the FDA classifies them as over-the-counter drugs, which means active filters must meet the GRASE standard — generally recognized as safe and effective — to be approved. This is a more demanding pathway than the cosmetic route used elsewhere.
How does Korea regulate sunscreen differently?
South Korea treats sunscreens as 'functional cosmetics,' a category that allows efficacy claims under a faster, cosmetic-style framework. This lets Korean manufacturers introduce new UV filters far more quickly than the US drug-approval process permits.
r/SkincareAddiction: 'Why does Europe and Korea get cool new sunscreen filters but the US is stuck with old ones?'