Applause for Bemotrizinol’s Approval in the US 

The recent approval of the new UV filter, bemotrizinol (BEMT), will have an immediate positive impact on the sunscreen industry, and its overall impact will be huge. It marks a turning point in the development of superior global sunscreen products in the US.

The path for approval has been long and arduous and has spanned nearly three decades starting with Ciba’s introduction of bemotrizinol (Tinosorb S) at the turn of the century, then to BASF which acquired Tinosorb S from Ciba, and finally to DSM with Parsol Shield.  

The regulatory path was daunting to say the least.  We formed the PASS Coalition in early 2000 primarily to work with US Congress and the FDA to introduce sorely needed new UV filters that are broad spectrum, more photostable that effectively reduce the damage to the skin from the longer wavelength UVA radiation.  We worked with Congress to introduce The Sunscreen Innovation Act (SIA) that was signed by President Obama into law in November 2014. That legislation went by the wayside until the CARES Act was introduced in 2020 during the pandemic, which was also largely ignored by the FDA in approving new UV filters.  Finally, the SAFE Sunscreen Standards Act was approved in 2025. 

After several meetings with the FDA, bemotrizinol was finally approved at 6% on June 9, 2026 as a Category I GRASE sunscreen UV filter. After the 60-day comment period, the new UV filter can be used in suncare products in the US commencing August 10, 2026.

DSM-Firmenich receives all the credit for sponsoring the OMOR (Over-the-counter Monograph Order Request) Tier I application. The company endured several years of ongoing communication with the FDA and complied with all their demands for toxicological, pharmacological, and safety tests to gain this landmark approval.  Most importantly, DSM-Firmenich submitted data in compliance of the MUsT test (Maximal Use Trial Test) at a considerable cost, time and effort.  The test used 75% of body surface area, administered four applications per day on multiple consecutive days on 162 patients.  The skin absorption level of BEMT was well below the 0.5ng maximum absorption level set by the FDA. We finally have a UV filter properly designed according to the 500 Dalton Rule which effectively prevents molecules from penetrating the skin.  It should be noted that all the organic absorbing UV filters approved in the US, except for ZnO and TiO2, are smaller molecules that are well below the 500 Daltons and are thus subject to skin penetration.

Bemotrizinol is a photostable, safe broad-spectrum molecule.  Its molecular weight (MW) is 628 g/mol with a triazine backbone structure with two octyl groups attached that are designed to decrease the water solubility of the molecule significantly. It is a yellowish solid and the use of specific emollients to solubilize this molecule is required. BEMT’s ultraviolet absorption is outstanding with two UV maxima at 310 nm and 343 nm.  The 310 nm absorption covers the UVB radiation very effectively with an Extinction Coefficient of 46,800, and the 343 nm absorption covers the UVA radiation with a huge Extinction Coefficient of 51,900. Note that Octisalate, for example, has a λmax at 308 nm with an Extinction Coefficient of 4,130 and a MW of 250!

BEMT is now approved everywhere in the world. It is compatible with every UV filter in commerce today.  This will allow hybrid formulations with ZnO and TiO2 for the first time in the US. 

Combinations of ZnO and TiO2 with the only effective avobenzone have not been allowed in the US. 

With this new development, manufacturers will accomplish a myriad of formulations and reduce actives significantly, that hitherto have not been permitted or practical in the US:

1. US sunscreen products will now be approved globally.
2. Hybrid formulations with ZnO/TiO2  and organic UV absorbing molecules are now permitted.
3. Bemotrizinol is a photostable molecule unlike the photo unstable Avobenzone. This also means that you will not need to add quenchers such as octocrylene, oxybenzone or the myriad so-called T-T quenchers to photostabilize avobenzone. Those T-T quenchers include Corapan TQ (DEHN), Oxynex ST (DESM), Polycrylene (Polyester-8), Solastay SI, Synoxyl HSS and others.
4. Since bemotrizinol is an efficient broad-spectrum (UVA and UVB)
   absorber, the need for non-FDA approved boosters such as salicylates, octocrylene and cinnamate derivatives are no longer required. The use of natural boosters with other attributes, however, would be highly recommended.
5. Bemotrizinol effectively covers the so-called 320 nm gap since all currently approved UV filters including avobenzone, homosalate, octisalate, octinoxate and even ZnO and TiO2 have minimal absorption in the 320 nm region.

More To Come?

This new approved molecule has been used safely and effectively for more than 20 years around the world. It is not covered by patents, but Congress allows the sponsor (DSM in this case) an 18-month exclusive term. Congratulations to DSM for their perseverance and sponsorship but, more importantly, we will soon have—hopefully—the first of many more-to-come effective, broad spectrum, photostable, safe and functional UV filters that finally will bring the US sunscreen products on par with sunscreen products across the world.  

Let us celebrate the upcoming superior protection from the ravaging rays of the sun that blisteringly shines in America!

Nadim Shaath

Alpha Research & Development Ltd
[email protected]

Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience in the sunscreen industry. He served as the Chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he published his new book entitled “Healing Civilizations: The Search for Therapeutic Essential Oils and Nutrients” Cameron Books, Petaluma, CA.