I’ve spent years working on this exact problem. So when the FDA finally approved bemotrizinol in June 2026, it wasn’t abstract news to me. It was the end of a very long process I’d had a front-row seat to.
What Happened?
In June 2026, the FDA issued a final order adding bemotrizinol to the over-the-counter sunscreen monograph, permitted at concentrations up to 6% and effective August 9, 2026. It’s the first new sunscreen active ingredient approved in the US in more than 20 years.
Bemotrizinol, also known as BEMT or by its European trade name Tinosorb S, has been used safely in sunscreens across Europe, Asia, and Australia since the early 2000s.
The approval followed the reformed OTC monograph pathway created by the CARES Act: a proposed order in December 2025, a public comment period, and then the final order. DSM-Firmenich, which submitted the request, holds an 18-month exclusivity period that extends to its licensees and partners.
Why Did It Take So Long?
Before 2020, US sunscreen ingredients were reviewed through a monograph system that had barely been updated since the 1970s. Getting a new UV filter approved could take decades, and often simply didn’t happen.
That is a large part of why the US has historically had fewer approved sunscreen filters than Europe or Asia, even though many of those filters have long safety track records abroad.
Bemotrizinol itself was first filed with the FDA back in 2005. It sat in that older, slower system for years until the CARES Act reforms in 2020 created a workable path forward. Even then, getting through the reformed process took several more years of additional studies and review.
What Was My Part in This?
This is where my work on the SAFE Sunscreen Standards Act with the Skin Cancer Foundation and the Personal Care Products Council comes in. I’ve spent real time on Capitol Hill making the case that American patients deserve access to the same broad-spectrum protection available almost everywhere else in the world.
When bemotrizinol was finally approved, DSM-Firmenich recognized that advocacy work directly, which meant a lot to me. This wasn’t a policy abstraction. It was about patients I see every week who couldn’t get the sunscreen technology available to people traveling from Seoul or Paris.
What Does This Mean Going Forward?
The pace from approval to shelf has been fast. Ultra Violette launched the first US bemotrizinol sunscreen, Unblock Screen SPF 50, on August 31, 2026, just weeks after the final order took effect. The brand could move quickly because it had already been formulating with BEMT internationally for years.
A second Ultra Violette product, Fave Screen SPF 50, is set for January 2027, and more brands are expected to follow as DSM-Firmenich’s supply agreements expand.
Bemotrizinol also won’t be the last of these approvals. The same reformed pathway that got this ingredient through is still open, and other filters with long international safety records could follow.
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References:
Spencer Fane: FDA’s First New Sunscreen Active Ingredient in Decades
HCPLive: FDA Adds Bemotrizinol, First New Sunscreen Ingredient in Decades
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