If you've spent any time on the beauty side of the Internet in the last few years, it's highly likely you've seen droves of people sounding the alarm on the effectiveness, and quality, of sunscreens sold in the US compared to those sold abroad. Sunscreens in Europe and Asia are highly-coveted by American consumers because they offer more advanced chemical UV filters—like Tinosorb S (BEMT), Tinosorb M, Mexoryl SX/XL (Ecamsule), Ethylhexyl Triazone, and DHHB—that are not approved for sale in the United States. However, there's a chance that might change soon.
On Dec. 11, the US Food and Drug Administration (FDA) announced its proposal for bemotrizinol (BEMT) to be approved as an active ingredient in over-the-counter sunscreens sold in the US. Per the FDA, bemotrizinol is a chemical sunscreen filter that "shows very low absorption through the skin" and provides strong broad-spectrum protection against ultraviolet A (UVA) and ultraviolet B (UVB) rays, both of which can both cause sun damage and premature skin aging at best and skin cancer at worst. It's also already an active ingredient in sunscreens available in Europe, Asia, and Australia. Should the action be approved, BEMT will be "generally recognized as safe and effective for use by adults and children six months of age and older," and companies will be allowed to use it in concentrations of up to six percent in their products.
This is pretty huge news considering the last time the US approved a new sunscreen filter was in 1999, almost 27 (!!!) years ago. At the moment, there are only 16 sunscreen filters that are FDA-approved, though zinc oxide and titanium dioxide (which are often found in mineral sunscreens and are known for causing a ghostly white cast) are the only ones that are "generally recognized as safe and effective" (GRASE) by the FDA. (Oxybenzone, avobenzone, and octinoxate are also approved and commonly used in chemical sunscreen formulas, but they're not GRASE.)
“This proposal signals real hope for public health,” says the Environmental Working Group's (EWG) acting chief science officer David Andrews, PhD., in a press release to media. “Mineral sunscreens are a top choice for consumers, but for those who prefer non-mineral products the ingredient options have been limited."
The [FDA] has historically moved too slowly in this area, leaving Americans with fewer [sunscreen] options than consumers abroad.
FDA Commissioner Marty Makary
The reason why American sunscreens seem to fall behind in effectiveness is because they're regulated by the FDA as over-the-counter drugs instead of cosmetics, so the process of approving new ingredients is a lot slower and more restrictive. In turn, US consumers are left with products containing outdated and potentially harmful ingredients. “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad," FDA Commissioner Marty Makary, MD, MPH said in a statement about the proposal. "We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products. Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”
This is long overdue for many reasons. For starters, plenty of people prefer chemical sunscreens to mineral formulas because they're easier to blend, but they also have a reputation for causing skin irritation, and studies have shown that some ingredients in chemical sunscreens can absorb into the bloodstream. The FDA reports that bemotrizinol is a non-irritating ingredient with a low-absorption rate, which could be good news for people with sensitive skin. Skin cancer also remains the most common type of cancer in the United States, and that's on top of the fact that sunscreen misinformation has been taking on a life of its own on the Internet in recent years, with some creators making claims that sunscreen is either unsafe or unnecessary—or both. So while everyone should be wearing sunscreen daily (particularly a product with a sun protection factor of at least 30), having product options that feature a modern, more effective ingredient (that's also safe) could lessen people's skepticism towards sun protection, and in turn, their potential for developing skin cancer.
“For years, Americans have been denied access to sunscreen ingredients that offer stronger UVA protection with fewer health concerns," Dr. Andrews adds in his statement. "Approving bemotrizinol would finally begin to close the gap between US consumers and the rest of the world.”
A spokesperson for the FDA says that the final order on the proposal is expected by summer or fall of 2026, and most manufacturers might be able to start marketing products with bemotrizinol by the end of next year. In other words, the new year is looking like it's going to be filled with exceptionally good (and well-protected) skin days.
