The U.S. sunscreen market is entering an important new chapter. The U.S. Food and Drug Administration has added bemotrizinol, also known as BEMT, to the list of permitted active ingredients under the OTC sunscreen monograph.
This update is meaningful for K-beauty sunscreen brands because BEMT has long been used in Korea, Europe, Japan, and other international markets as a modern UV filter. It is known for helping provide broad-spectrum UVA and UVB protection, strong photostability, and elegant sunscreen formulations with reduced white cast.
However, this change should be understood carefully.
As discussed in a recent conversation between CGETC and ANCELL, CGETC’s long-term cosmetics compliance partner, the approval of one ingredient does not mean that every sunscreen product containing BEMT is automatically ready for the U.S. market.
ANCELL explained that BEMT has now been added as a permitted sunscreen active ingredient, but U.S. sunscreen products are still regulated as OTC drugs, not general cosmetics. This means brands must continue to meet U.S. OTC drug requirements before selling sunscreen products in the United States.
One of the most important points is that brands must review the full UV filter system, not just BEMT. Many K-beauty sunscreens use BEMT together with other UV filters such as Tinosorb M, Uvinul A Plus, or Mexoryl-related ingredients. Some of these ingredients may still not be permitted under the U.S. OTC sunscreen monograph. If a product contains even one UV filter that is not permitted, the product may still face challenges entering the U.S. market as an SPF sunscreen.
ANCELL also emphasized that sunscreen compliance in the U.S. goes beyond ingredient review. Brands and manufacturers may need to evaluate Drug Establishment Registration, Drug Listing, U.S. Agent requirements for foreign manufacturers, OMUFA fees, and compliance with drug CGMP standards. Cosmetics GMP or ISO 22716 may not automatically satisfy U.S. OTC drug manufacturing requirements.
Testing and labeling are also critical. Korean SPF or PA testing standards do not automatically replace FDA requirements. For the U.S. market, sunscreen products should be reviewed for FDA-compliant SPF testing, Broad Spectrum testing, Water Resistance testing when applicable, and stability data. The label must also follow the Drug Facts format, including Active Ingredients, Uses, Warnings, Directions, and Inactive Ingredients.
For CGETC, this is where regulatory preparation and U.S. market execution connect. CGETC supports brands with U.S. import, IOR, customs clearance, retailer inbound, and B2B/B2C logistics operations, while ANCELL provides specialized compliance review to help ensure products are prepared according to U.S. regulatory expectations.
The key message is clear: the ingredient has opened, but the market has not automatically opened.
BEMT is an important opportunity for K-beauty sunscreen brands, but brands should not ship products first and review compliance later. Before entering the U.S. market, brands should review the complete formula, manufacturing standards, testing data, Drug Facts labeling, import structure, and retailer requirements.
CGETC and ANCELL will continue to work together to support K-beauty brands beyond simply bringing products into the United States. The goal is to help brands build a structure that allows their products to be sold safely, compliantly, and sustainably in the U.S. market.
Key Checklist for Brands
1. Review the full UV filter system
Confirm whether all active sunscreen ingredients are permitted under the U.S. OTC sunscreen monograph.
2. Check BEMT usage conditions
Review whether the concentration and formula conditions meet the applicable U.S. requirements.
3. Prepare OTC drug registration requirements
Evaluate Drug Establishment Registration, Drug Listing, U.S. Agent requirements, and OMUFA fee obligations.
4. Confirm manufacturing standards
Check whether the manufacturer can comply with U.S. drug CGMP requirements.
5. Prepare FDA-compliant testing and labeling
Review SPF, Broad Spectrum, Water Resistance testing, stability data, and Drug Facts label requirements.
BEMT is a step forward for sunscreen innovation. For K-beauty brands, the next step is preparation.