FDA Approves First New Sunscreen Ingredient in Decades

“The United States has historically lagged much of the world in sunscreen chemistry,” says Melanie Palm, MD, a dermatologist and cosmetic surgeon at Art of Skin MD in Solana, California. Sunscreens made with bemotrizinol have been available outside the U.S. for decades.

“For more than 25 years we have been working with a fixed menu of roughly 16 approved filters, and almost every one of them is a specialist rather than a generalist. Bemotrizinol is different.”

Bemotrizinol joins just two other sunscreen ingredients that the FDA considers "generally recognized as safe and effective" (GRASE): zinc oxide and titanium dioxide. While these two ingredients are mineral sunscreens, bemotrizinol is a chemical ingredient.

What Is Bemotrizinol?

Bemotrizinol is a chemical UV filter that provides protection against UVA and UVB rays. “Most of the sunscreen options on the shelf in the U.S. only block UVB,” says Jamie Alan, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University in East Lansing.

“While UVB is what typically causes sunburns, UVA is deep-penetrating and can drive aging and cancer. Right now, only zinc oxide, titanium dioxide, or avobenzone can block UVA and UVB,” says Dr. Alan.

Bemotrizinol is a large molecule chemical, which lowers the amount of the ingredient that can be absorbed into the body, per the FDA. The larger molecule is also “not likely to impact the environment as much because it’s not taken up by plants,” Alan says.

Another benefit of bemotrizinol is that it’s photostable, which means it doesn’t easily break down in sunlight, Alan says. “Avobenzone, our main organic UVA filter, is notoriously photolabile unless carefully stabilized,” says Adam Friedman, MD, a professor and the chair of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC.

“Bemotrizinol helps address that gap because it absorbs in both the UVB and UVA range and can also improve the stability of other filters in a formulation,” Dr. Friedman says.

Dr. Palm calls bemotrizinol “elegant and lightweight,” noting that “chemists can build broad-spectrum sunscreens that feel good on the skin — which is the single biggest determinant of whether a patient actually applies it every day.”

Evidence Supports the Safety of Bemotrizinol

A large existing body of research and real-world data support the safety of bemotrizinol.

“Based on the peer reviewed data available, I do not have a specific safety concern that would make me hesitant about bemotrizinol,” Friedman says. “That said, ‘safe’ does not mean ‘magic.’ Safety and performance still depend on the final formulation, concentration, labeling, water resistance, patient use, and real world reapplication.”

Bemotrizinol has also been through rigorous testing. “What makes this approval so reassuring is that bemotrizinol was not waved through on a cosmetic technicality,” Palm says.

“It went through a full FDA new-drug-caliber review under modern safety standards, supported by one of the most extensive safety dossiers ever assembled for a sunscreen ingredient: human safety studies, animal toxicology, photostability and degradation testing, pediatric relevance assessments, maximal-use absorption studies, efficacy testing, and a formal environmental assessment,” she says.

Bemotrizinol has also been reliable in other parts of the world. “This has been used in other countries for a while,” Alan says. “I have confidence in the [safety] claims.”

Dermatologists Say the Approval Is Coming at the Right Time

While regular sunscreen use has been linked to a lower risk of skin cancer, data suggests that fewer than 60 percent of American adults consistently use sunscreen.

Bemotrizinol’s features may help encourage more people to use sunscreen regularly, according to Palm. “A more capable filter that people are willing to wear consistently is, in my view, the most important kind of progress we can make in sun protection,” she says.

Overall, experts say they’re excited about bemotrizinol’s approval. “I would frame this as a meaningful advance, not a license to abandon the fundamentals: broad-spectrum SPF 30 or higher, adequate amount, reapplication, shade, hats, sunglasses, and UPF clothing,” Friedman says.

“I will be buying some when it comes out,” Alan says.

When Can You Buy Bemotrizinol Sunscreen?

The FDA did not share an exact timeline for when products with bemotrizinol will hit the market.