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If you're familiar with the sunscreen world—and you should be, considering we should all be wearing SPF every single day—you know that America is way behind in sunscreen innovation. This is in part because in the US, sunscreen is regulated as a drug rather than a cosmetic, which means it has to undergo robust testing via the Food & Drug Administration before hitting shelves. However, the FDA has finally taken a step toward approving a new active sunscreen ingredient (also called a filter), which would be the first major sunscreen-related approval since 1999—yes, 1999!
On December 11, the administration announced a formal proposal to add bemotrizinol to the list of approved active ingredients for over-the-counter sunscreens. According to the FDA, bemotrizinol (or BEMT) “provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation.” Should BEMT approvals be finalized, it will be considered safe and effective by the FDA and recommended for use for adults and children ages six months and older.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA commissioner Marty Makary, M.D., M.P.H., said in a statement. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
In the past, the FDA has declined to comment on its approval timelines, and it'll likely be a long while until products formulated with BEMT are approved and made available. In the meantime, interested parties can review the full amendment proposal. Starting December 12, anyone interested can participate in the public comment process, which allows Americans to share direct feedback with the FDA for or against a proposal. If you've got strong feelings about sunscreen, it may be time to hop in the FDA's comments.
Cosmetic chemist Kelly Dobos previously wrote in Allure that chemists in the US have a “pretty limited toolbox” for sunscreen formulation: just 16 active sunscreen ingredients, only eight of which are commonly used. For contrast, in Japan, formulators can choose from over 30 approved filters. According to Dobos, who attended the 2025 Sunscreen Symposium, BEMT is manufactured by DSM-Firmenich, which has been trying to get the ingredient approved in the US for 20 years; it cost them roughly $20 million to bring it to market.
BEMT approval will give cosmetic chemists another ingredient in their toolbox, and Dobos praises it for its efficiency. BEMT provides “true broad-spectrum protection with two distinct absorption peaks, one in the UVA range and one in UVB,” she explains, which means better defense against both sunburns and aging rays. “Unlike older filters that often require high concentrations to achieve adequate SPF, BEMT allows chemists to use lower overall levels of actives while still meeting high SPF and UVA protection targets,” Dobos tells Allure. It may also improve the sunscreen experience: “We can make products with lighter texture and less greasiness in formulations. And, like other organic filters, it's transparent on the skin.”
The American Academy of Dermatologists is also on board with BEMT. “Unprotected exposure to UV rays is a major risk factor for skin cancer, the most common cancer in the United States,” AAD president Susan C. Taylor, MD, FAAD, said in a statement, noting that one in five Americans will develop skin cancer in their lifetime. “Because dermatologists see firsthand the impact that skin cancer has on patients and their families, they recommend everyone apply sunscreen, seek shade, and wear protective clothing to protect their skin from sunburn, early skin aging, and skin cancer. The Academy has been advocating for many years for the availability of more sunscreen options for US consumers. The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients.”
Dobos says she's “very excited” about BEMT and putting it to work in sunscreen formulations. “Many times in the past, I felt like Charlie Brown when Lucy pulls that football away just as he's about to attempt a kick, as progress would start and stall,” she says. “I've been following this my entire career. But this time, it finally feels like we're really going to get a new sunscreen active.”
