Why Korean Sunscreens Are Being Reformulated for the U.S.
Superior formula must be accompanied by rigorous compliance
Korean sunscreens have built a cult following in the United States for their lightweight texture, strong UV protection, and skincare-grade formulations. But beginning in early 2025, several of the category’s most popular products quietly began disappearing from U.S. shelves — not because of safety concerns, but because of a longstanding regulatory divide.
The core issue is classification. In the United States, sunscreens are regulated as over-the-counter (OTC) drugs under the Federal Food, Drug, and Cosmetic Act, while Korea’s Ministry of Food and Drug Safety treats them as “functional cosmetics” — a category that does not exist in U.S. law (University of Miami International and Comparative Law Review, 2024). The FDA has approved only 16 UV filters, and no new chemical filter has been added since 1999. South Korea’s MFDS, by contrast, permits roughly 30 filters, including next-generation ingredients such as bemotrizinol (Tinosorb S) and Uvinul A Plus that power many top-selling Korean formulations.
The regulatory environment tightened further with the Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022. As of July 1, 2024, cosmetics manufacturers — including foreign facilities — must register with the FDA and list every marketed product (WWD, 2024). Although sunscreens themselves are classified as drugs and exempted from many MoCRA provisions, the law has increased compliance scrutiny across the industry and prompted Korean brands to reevaluate their U.S. regulatory posture (ArentFox Schiff, 2024).
In late January 2025, Beauty of Joseon began discontinuing U.S. sales of its viral Relief Sun: Rice + Probiotics SPF50+ and several related SPF products, moving toward FDA-compliant formulations after FDA warnings were issued (Cosmi-Blogs, 2025). Fellow Korean brand Skin1004 followed with similar pullbacks.
A potential turning point is under review. In October 2024, ingredient supplier DSM-Firmenich submitted the first Over-the-Counter Monograph Order Request (OMOR) Tier 1 application for bemotrizinol — a filter used abroad for more than two decades — under the updated FDA review process (Covalo, 2024). If approved, it would be the first new UV filter added to the U.S. monograph in over 25 years.
For Korean sunscreen brands, the U.S. now demands a distinct compliance pathway from pure skincare: dual drug-cosmetic oversight, OTC monograph constraints, and a filter list that has barely changed since the late 1990s. Navigating that divide is reshaping which formulations reach American shelves — and which stay on.