FDA approves its first new sunscreen filter in 20 years: bemotrizinol
The US sunscreen market just got a rare change. On June 9, 2026 the FDA finalized an order adding bemotrizinol (the filter many people know as Tinosorb S) to the over-the-counter sunscreen monograph.
The short version
- Allowed at up to 6%
- Broad-spectrum UVA and UVB protection, with low skin absorption according to the FDA
- Considered safe for adults and children 6 months and older
- Proposed December 2025, comments closed January 2026, final order in June
- Companies can now market sunscreens with it without an individual drug application, as long as they meet the monograph
Why the industry cares The US has had one of the narrowest filter lists in the world, which is a big reason Korean sunscreens rarely ship there unchanged. One new filter does not make a Korean formula US-ready overnight, but it gives formulators another real option. Sunscreen is still an OTC drug in the US, so testing and labeling rules still apply separately.
If you work on sunscreens for the US, does this change how you plan your next formula?
Source: FDA — FDA Expands Sunscreen Options for the First Time in 20 Years
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