The U.S. is set to welcome a new and improved sunscreen ingredient. Today, the Food and Drug Administration (FDA) has approved the addition of bemotrizinol, a highly effective chemical filter long used in sunscreens across Asia and Europe, to its list of approved active ingredients for over-the-counter sunscreens. This marks the first new entry to the list in over two decades.
Known as BEMT, bemotrizinol increases the total number of approved active sunscreen ingredients in the U.S. to 17, a figure significantly lower than Europe, where over 30 filters have been sanctioned. Although the FDA’s decision follows just seven months after its initial proposal, critics have highlighted that the prolonged regulatory process delayed bemotrizinol’s approval, with the application originally submitted in 2005. The Environmental Working Group, an advocacy organization focused on environmental health, argues that this delay has left U.S. sunscreens lagging in providing enhanced protection against harmful ultraviolet (UV) rays. Experts consider today’s approval a positive step toward better sun protection for consumers.
The expansion of sunscreen ingredient options in the U.S. is “a pretty big deal,” according to AJ Addae, a chemist and doctoral candidate at the University of California, Los Angeles, who specializes in cosmetics and sunscreen formulations. “It’s definitely something that we haven’t had in a very long time.”
On supporting science journalism
If you’re enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription, you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today.
How Bemotrizinol Works
Sunscreen filters are generally divided into two categories: inorganic, known as “physical,” and organic, known as “chemical.” Physical filters, such as titanium and zinc, are mineral-based and often leave a white residue on the skin. Chemical filters, including avobenzone, octocrylene, and homosalate, are clear when applied but can feel oily. According to Addae, there are more organic filters than inorganic ones, but the U.S. approves fewer than other regions worldwide.
Contrary to common belief, both filter types mainly function by absorbing UV light and converting it into heat, which is then released from the skin, explains Saranya Wyles, a dermatologist at the Mayo Clinic in Minnesota. While all sunscreens can reflect some light, inorganic filters generally reflect a bit more, adds Addae.
UV radiation is categorized into two types: UVA and UVB. UVB is a high-energy form of radiation often associated with sunburns and can cause genetic mutations leading to skin cancer. Meanwhile, UVA rays have gained attention for their impact on skin health, being longer-wavelength and capable of deeper skin penetration, which can degrade skin structure and create harmful, aging molecules.
In the U.S., sunscreen testing primarily focuses on a product’s ability to absorb UV light, specifically UVB, notes Addae. This is how the sun protection factor (SPF) is determined; however, it does not account for UVA protection. According to an analysis by the Environmental Working Group, U.S. sunscreens provide only 24 percent of the UVA protection indicated on SPF labels.
“When we think about a sunscreen, we want something to be broad spectrum,” Wyles says, meaning it covers both UVA and UVB. She adds, “What’s so exciting about this new BEMT filter is that it has more coverage in that UVA spectrum” compared with other organic filters. BEMT effectively shields against the “deeper UVA” rays often associated with photoaging.
Safety and Stability Properties
Bemotrizinol is backed by extensive safety and efficacy tests across various countries and real-world applications. Developed in the late 1990s by the now-defunct Switzerland-based company Ciba Specialty Chemicals, it was adopted in European sunscreens in 2000, with Canada and several Asian countries following suit.
“A ton of safety data have had to be accrued in a lot of different populations,” Wyles states, emphasizing the need for significant funding to gather the necessary data for U.S. approval.
Bemotrizinol is now the first sunscreen filter to receive FDA approval since 1999 and the first organic filter to achieve the safety and effectiveness standard known as generally recognized as safe and effective (GRASE) for over-the-counter drugs or ingredients not requiring full regulatory approval. “The GRASE designation is huge,” Addae remarks.
Addae believes this will challenge the perception that inorganic filters are safer and more effective than organic ones. “This shows that there can be organic filters that are determined GRASE,” she says.
While it is difficult to definitively determine the healthiness of sunscreen ingredients for people, Addae notes that research has shed light on how sunscreen filters interact with our bodies. Chemically, BEMT has larger chromophores, which are light-absorbing molecules, than other organic filters, reducing concerns about adverse biological interactions. Researchers in pharmacology and dermatology use the “500 dalton rule,” suggesting molecules with a weight over 500 daltons are typically too large to penetrate the skin.
“BEMT exceeds this limit quite well,” Addae says. “I think that’s likely a large reason why the GRASE status was on the table for this particular filter.”
Investigations into whether BEMT breaks down in pool water are ongoing, and it is unclear if any resulting chemical by-products might irritate or harm the skin. However, evidence indicates that BEMT remains stable and lasts longer in sunlight than other filters. “BEMT is one that does stay on longer, but this doesn’t mean you can apply this and then you don’t have to reapply for a long time,” Wyles points out. “That degradation curve varies for everybody.”
The FDA assessed BEMT’s safety and efficacy at concentrations up to 6 percent and examined its interactions with other sunscreen filters and ingredients. With a maximum allowable concentration of 6 percent in formulations, Wyles believes BEMT will not completely replace existing U.S. filters.
“A lot of times, you’re not going to see BEMT standing alone; it’s going to be combined with other sunscreen filters,” Wyles notes.
The Future of UV Filters
Researchers are monitoring BEMT’s approval to see how it might influence the approval of other UV filters in the U.S. Wyles suggests that other filters in the BEMT family could receive similar approvals. Mexoryl 400, another organic filter known for its UVA coverage, is increasingly included in sunscreens made in Asia and Europe. “I can see that coming to the U.S. at some point,” Wyles says.
Addae, who established a research-and-development lab for cosmetic chain products, recently collaborated with colleagues at U.C.L.A. to develop a mineral-based filter with reduced white cast. By altering the chemical properties of zinc oxide, she minimized aggregation that leads to white cast. Although this new filter effectively absorbed UV rays, it was more effective against UVB than UVA. Further testing is required, but the filter would not require new regulatory approval, she says.
BEMT-containing sunscreens are expected to be available in the U.S. later this year. The Dutch company DSM Nutritional Products will be the first to market its BEMT-formulated sunscreen, Parsol Shield, as reported by the Associated Press. The company has an 18-month exclusivity period after which other manufacturers will be permitted to use the ingredient. Addae adds that it will take time for U.S. chemists and companies to integrate the filter into new products and establish best practices.
“At the end of the day, what matters is that people wear their sunscreen, no matter what’s in it,” she concludes.
Editor’s Note (6/5/26): This is a breaking news story and may be updated.
