The US Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients — the first new addition in more than 20 years.
Bemotrizinol has been used as a sunscreen ingredient in Europe and many other countries worldwide for years.
It is manufactured under the brand name PARSOL Shield by dsm-firmenich.
"As promised in the Trump Administration's MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the US 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.
Sunscreens contain either mineral or chemical UV light filters. Mineral versions are able to block both UVA and UVB light, but can leave a white cast on the skin.
Current chemical versions available in the US can only protect against either UVA or UVB — not both. Thus, formulators have traditionally used a mix of ingredients in order to achieve broad-spectrum protection.
Chemical sunscreens also tend to break down quickly in the sun, requiring regular reapplication.
Bemotrizinol is a broad-spectrum chemical UV light filter on its own, meaning it can block both UVA and UVB light. It is also much more stable than other sunscreens currently on the market.
"This is exactly the kind of progress we can achieve when we modernise our processes and apply sound science to regulatory decisions," said Dr Mike Davis, Acting Director of the FDA Centre for Drug Evaluation and Research (CDER).
The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.
The FDA considers bemotrizinol to be generally recognised as safe and effective (GRASE) for use in sunscreens for adults and children aged 6 months and older.
dsm-firmenich, the manufacturer of PARSOL Shield, said the decision would open "new possibilities for formulators across the industry."
It stated the new active ingredient would now allow suncare product formulators to achieve lightweight sunscreen textures with strong photostability and formulation flexibility.
Parand Salmassinia, Beauty & Care President at dsm-firmenich commented: "The FDA approval of PARSOL Shield represents an important step forward for sun protection in the United States."
"It builds on years of scientific leadership and regulatory excellence, while helping address a longstanding innovation gap in the market. After more than two decades, this new active ingredient delivers what our customers have been waiting for."
It gives suncare manufacturers the flexibility to develop next-generation, globally scalable solutions that enhance the consumer experience.
The ingredient also has a strong environmental profile, helping suncare brands meet evolving sustainability expectations and reporting requirements.