The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, a new chemical UV filter for use in sunscreens, marking the first such approval in the United States in almost 30 years. Dermatologists and industry experts view the development as a significant advancement for sun protection products available to American consumers.
Broad-Spectrum UV Protection and Photostability
Bemotrizinol offers protection against both UVA and UVB rays, a characteristic dermatologists have sought in sunscreen ingredients. UVA rays contribute to premature aging and wrinkles, while UVB rays cause sunburns. Both types of UV radiation can lead to skin cancer. While sunscreens previously available in the U.S. provided good protection against UVB rays, their efficacy against UVA rays was often dependent on ingredients like avobenzone. However, avobenzone is not fully photostable, meaning its protective qualities can degrade when exposed to sunlight, and its breakdown can potentially cause skin irritation, according to cosmetic chemist Kelly Dobos and senior scientist Alexa Friedman of the Environmental Working Group (EWG).
In contrast, bemotrizinol provides its own broad-spectrum protection and is photostable, breaking down more slowly in sunlight. This means it can offer more consistent protection even if sunscreen reapplication is delayed beyond the recommended two-hour interval, though reapplying every two hours remains advised.
Global Use and Rigorous U.S. Approval Process
Bemotrizinol has been in use in sunscreens in Europe and Asia for decades. Its approval in the U.S. followed a lengthy process, taking approximately 20 years. This extended timeline is attributed to the FDA’s regulation of sunscreens as over-the-counter drugs, which requires extensive testing for safety and efficacy. The European company DSM-Firmenich reportedly invested at least $18 million over more than two decades to secure FDA approval for the ingredient.
Safety Profile and Consumer Trust
The extensive testing undertaken for FDA approval has resulted in a robust safety profile for bemotrizinol, with more supporting data available than for many other chemical sunscreen ingredients currently approved in the U.S. Animal studies indicated no concerns regarding reproductive harm, and human clinical trials found it to be non-irritating, even with repeated application. Additionally, bemotrizinol’s larger molecule size limits its absorption into the bloodstream, a point of concern for some other chemical UV filters where absorption has been detected. Experts suggest that a sunscreen ingredient with a strong safety record and perceived trustworthiness is crucial for encouraging consistent consumer use, especially given the prevalence of skin cancer.
Improved Sunscreen Formulations
Previously, zinc oxide was the primary ingredient available in the U.S. that offered similar benefits, including photostability, minimal absorption, and broad-spectrum protection. However, mineral-based sunscreens like those containing zinc oxide can leave a visible white cast on the skin, which can be particularly noticeable on darker skin tones. Bemotrizinol, being transparent on the skin, eliminates this aesthetic drawback. Its ability to provide comprehensive UV protection on its own also means it may require fewer stabilizing ingredients in formulations. This is expected to lead to more cosmetically elegant, less greasy sunscreens.
DSM-Firmenich holds exclusive marketing rights for bemotrizinol in the U.S. under the brand name Parsol Shield for 18 months. The company anticipates that the first sunscreens featuring this ingredient will be available in American stores by September.
Norman Pearlstine is the Chief Editor of News Raise and focuses on Business news. His responsibility is to oversee the editorial content including business, commodities, personal investments and the stock market.
