The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, a sunscreen ingredient not previously available in the United States, marking the first such approval in more than two decades. This development brings a new option for consumers seeking protection from harmful ultraviolet (UV) rays, addressing calls from experts for more advanced sunscreen technology.
Bemotrizinol, also known as BEMT, is an oil-soluble chemical filter that provides broad-spectrum protection against both UVA and UVB rays. UVA rays penetrate deeply into the skin, contributing to premature aging and skin cancer, while UVB rays directly damage cellular DNA, increasing the risk of various skin cancers, including melanoma. Dermatologists have lauded bemotrizinol for its efficacy and safety profile, noting its widespread use and positive reception in Europe and Asia for years.
"This is a meaningful advancement for sunscreen innovation in the US," said Dr. Jessica Weiser, a dermatologist and founder of Weiser Skin MD. "Bemotrizinol has been widely used in Europe for years, and dermatologists have long been aware of its ability to provide broad-spectrum protection against both UVA and UVB rays."
Previously, the FDA had only designated two active ingredients as Generally Recognized As Safe and Effective (GRASE) for sunscreens: zinc oxide and titanium dioxide. These ingredients are commonly found in mineral sunscreens, which can sometimes leave a white residue. Bemotrizinol, however, is noted for its photostability, meaning it remains effective longer when exposed to sunlight, and its low absorption into the skin, qualifying it for GRASE status.
Experts suggest that bemotrizinol offers superior UVA protection compared to other chemical filters currently available in the U.S. While existing U.S. chemical sunscreens often excel at UVB protection against sunburn, their coverage against UVA rays, which are linked to pigmentation and collagen breakdown, is estimated to be significantly lower. Bemotrizinol also demonstrates efficacy at lower concentrations and is compatible with other sunscreen ingredients, potentially leading to more cosmetically elegant and user-friendly formulations.
"We have been stuck in the past, while the rest of the world enjoys superior formulas with lightweight, elegant, safer sunscreens with better protection," stated Gary Goldenberg, a board-certified dermatologist. The availability of new ingredients like bemotrizinol is seen as a step towards encouraging more consistent daily sunscreen use.
The first U.S. products featuring bemotrizinol will be marketed under the name Parsol Shield by Dutch manufacturer DSM Nutritional Products. Other manufacturers will gain access to the ingredient after an 18-month exclusivity period. The FDA has emphasized the importance of timely access to safe and effective consumer products.