FDA Approves Bemotrizinol as New Sunscreen Ingredient for U.S. Market

Melanoma expert Ashani T. Weeraratna, PhD, from the Johns Hopkins Bloomberg School of Public Health, expressed her enthusiasm, noting that she no longer needs to source sunscreen from Europe.

Ultraviolet (UV) radiation from the sun can damage DNA in skin cells, leading to various forms of skin cancer, including basal cell carcinoma, squamous cell carcinoma, and melanoma. According to the AACR Cancer Progress Report 2025, UV radiation accounts for 92% of melanoma cases and 4.6% of overall cancer cases. The National Cancer Institute predicts that in 2026, approximately 112,000 individuals in the U.S. will be diagnosed with melanoma, and around 8,510 will die from it.

Using broad-spectrum sunscreen is recommended to reduce the risk of skin cancer. Weeraratna discussed how bemotrizinol compares to currently available options and what consumers should know about it.

Bemotrizinol is now recognized as generally recognized as safe and effective (GRASE) by the FDA, joining zinc oxide and titanium dioxide as approved active ingredients. Although other ingredients are allowed in sunscreens, including chemical filters like oxybenzone, the FDA requires more data on their long-term safety.

Weeraratna explained that while zinc and titanium act as physical blockers reflecting UV rays, bemotrizinol works by remaining on the skin's surface and converting UV rays into heat that dissipates quickly.

Concerns about the safety of certain sunscreen ingredients were raised in 2019 after an FDA study indicated that chemicals like avobenzone and oxybenzone could be absorbed into the bloodstream. Weeraratna clarified that, despite these findings, the presence of these ingredients in the bloodstream does not necessarily indicate harm. The FDA continues to recommend these sunscreens due to a lack of reported real-world harms. Furthermore, bemotrizinol's larger molecular size means it is less likely to penetrate the skin compared to smaller chemical filters.

Weeraratna noted that bemotrizinol remains stable in sunlight and is gentler on sensitive skin, leading to fewer allergic reactions than other filters.

In terms of protection, effective sunscreens must guard against both UVA and UVB rays. While zinc oxide protects both but may leave a residue, titanium dioxide primarily guards against UVB rays. Bemotrizinol, however, has been shown to effectively protect against both types. Additionally, it can stabilize other less stable ingredients, enhancing overall efficacy.

Weeraratna stressed that regardless of the benefits of bemotrizinol, it is crucial to reapply sunscreen every two hours for maximum effectiveness. She advised choosing broad-spectrum products with an SPF of at least 30. The first bemotrizinol-based sunscreen in the U.S. is expected to hit the market later this year.

Common misconceptions about sunscreen usage involve application amounts and frequency. Weeraratna recommends using at least a shot glass full of sunscreen for the arms, torso, and legs and reapplying every two hours, particularly when swimming or sweating. She emphasized that UV rays can penetrate clouds, so it is essential to wear sunscreen even on overcast days.

"Skin cancer is a real and common threat, and regular sunscreen use has been proven to prevent it," Weeraratna stated. "The benefits of wearing sunscreen far outweigh any theoretical risks from its ingredients." As summer approaches, she encourages people to make sunscreen a regular part of their outdoor routine.