The US Food and Drug Administration (FDA) has added DSM-Firmenich’s bemotrizinol to its list of permitted sunscreen active ingredients, the first addition since 1999.
Commercially known as Parsol Shield, bemotrizinol can now be used in over-the-counter sun care products without the need for additional pre-market approval.
Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body.
The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children six months of age and older.
Bemotrizinol has been approved across much of the world as an active ingredient in sunscreen.
FDA finalized this action within seven months of issuing the proposed order.
“As promised in the Trump Administration’s MAHA Strategy Report, the Department of Health and Human Services (HSS) is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy Jr.
“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products," he added.
DSM-Firmenich said the approval marks a major milestone for sunscreen innovation and public skin health in the US, helping expand access to next-generation UV protection while opening new possibilities for formulators across the industry.
“Parsol Shield approval represents an important step forward not only for dsm-firmenich, but for the future of sun protection in the US,” said Parand Salmassinia, Beauty & Care President at DSM-Firmenich.
“This milestone reflects years of scientific leadership, regulatory collaboration, and commitment to bringing meaningful innovation to consumers,” she added.
