After more than two decades of clinical research, paperwork, and red tape, the Food and Drug Administration’s (FDA) approval of UV filter bemotrizinol (BEMT) went into effect this past Sunday, August 9. BEMT is the first sunscreen active to be approved by the FDA in more than 25 years.
As BeautyMatter previously reported, BEMT is nothing new. Although BEMT has been used in Europe, Asia, Australia, and Canada for more than 25 years, US brands can only now formulate with it due to the FDA’s clunky and lengthy monograph approval process for over-the-counter (OTC) drugs. But brands that want to bring sunscreens with BEMT to market during the next 18 months will have to pay the BEMT tax.
When the FDA approved BEMT for GRASE (Generally Recognized As Safe and Effective) status in June, DSM-Firmenich was granted 18-month marketing exclusivity because it was the global ingredient conglomerate’s application that got approved (read: they spent the years of research and millions of dollars). Until this week, DSM-Firmenich’s exclusivity effectively blocked other US manufacturers from selling BEMT. Now there is one notable exception: BASF.
BASF has secured co-exclusive US rights to market and sell BEMT, branded as Tinosorb S, under a supplemental license agreement with DSM Nutritional Products.
The two companies have a long history with BEMT. Ciba Specialty Chemicals, which BASF acquired in 2009, developed and commercialized the filter as Tinosorb S in the 1990s. BASF took the ingredient global but did not pursue the costly US approval process. In 2018, DSM-Firmenich stepped in as the financial and regulatory sponsor, relying in part on BASF’s legacy research data to build the application that ultimately won FDA approval.
In other words, brands can source BEMT during the exclusivity period from either DSM-Firmenich, which markets it as Parsol Shield, or BASF, which sells it as Tinosorb S.
When BeautyMatter asked Montserrat Franco Rojas, Head of Global Communications at BASF Care Chemicals, about the relationship between the two companies and how BASF was granted co-exclusivity, she pointed to the current monograph, which states that the exclusivity period applies to the order requestor, which includes licensees. “With respect to BEMT, while DSM was the FDA order requestor, BASF has a license agreement with DSM that allows BASF the right to market and sell bemotrizinol in the United States during the FDA's 18-month exclusivity period,” Franco Rojas said.
Carl D’Ruiz, Senior Manager of Beauty & Care Science, Advocacy & Business Development in North America for DSM-Firmenich, told BeautyMatter that the company chose to grant BASF the limited sublicense “because it represented the fastest and most responsible path to bringing this important UV filter to the US market.”
D’Ruiz said that by combining BASF’s legacy nonclinical data with DSM-Firmenich’s human [clinical data] package, “we were able to help avoid unnecessary additional animal testing while accelerating access to more advanced UV protection for US consumers.”
As of press time, only a handful of brands have publicly announced they paid to skip the 18-month line, though industry insiders expect others to quietly hit the market over the next six months. For now, Ultra Violette, CeraVe, and Kenvue’s Neutrogena are the only brands actively building consumer buzz around sunscreens containing the newly approved filter.
Australian indie brand Ultra Violette has used BEMT in the majority of its range sold outside the US since the brand launched in 2019, and will use DSM-Firmenich’s Parsol Shield. “Our chemists are incredibly familiar with working with bemotrizinol,” Ultra Violette co-founder Ava Matthews told BeautyMatter.
“This familiarity is a benefit to us for many reasons: knowing which filter combinations provide ideal broad-spectrum coverage, as well as there being some intricacies that can require thorough solubilization, especially in less viscous formulations,” Matthews said. BEMT provides “very efficient” broad-spectrum protection, can reduce the overall chemical load, and potentially make formulations feel more wearable and elegant, according to Matthews.
Ultra Violette’s other founder, Bec Jefferd, told BeautyMatter that according to anecdotal evidence, sunscreen with BEMT can be better tolerated by skin that tends to react to traditional UV filters, with “less stinging or eye burn.”
The brand already has two of its sunscreens containing Parsol Shield cleared to launch under the monograph framework. Customers can expect Ultra Violette’s first product to hit the shelves late September/ early October and the second in January 2027, according to Matthews.
Neutrogena will be Kenvue’s first brand to adopt Parsol Shield, according to a Kenvue representative. “What excites us most is that BEMT gives us another formulation tool, allowing us to create more elegant, lightweight sunscreen textures,” the representative told BeautyMatter. “We see sunscreen as one of the most important tools available to help protect skin health, yet too many people still do not use sunscreen consistently.”
According to the company representative, Neutrogena is working toward integrating BEMT into its sunscreen innovation pipeline, with products available to consumers soon.
A CeraVe representative told BeautyMatter, “CeraVe is always exploring innovations that can advance dermatologist-developed sun protection. The FDA approval of bemotrizinol is a meaningful advancement for the category, and we’re excited about the potential it represents for the future of sunscreen.”
FDA approval is just the first hurdle. In addition to meeting the FDA’s OTC sunscreen monograph requirements, manufacturers will have to meet the quality and purity specifications established under the new USP (United States Pharmacopeia) BEMT monograph, which will go into effect on October 1 of this year.
“Those USP standards reflect impurity limits and specifications that are aligned with FDA's review of our OMOR [OTC Monograph Order Request] Tier 1 submission and the associated safety assessment,” D’Ruiz said. “In other words, FDA authorization is only part of the equation; suppliers must also demonstrate compliance with the applicable USP quality standards for BEMT.”
The price of entry may be steep, but as BEMT sunscreens begin hitting shelves later this year, more brands are likely to decide that first-mover advantage is worth the premium. After more than 25 years without a new UV filter, the US sunscreen category finally has a reason to move quickly. And for the next 18 months, getting there first comes at a price.