Bemotrizinol FDA approval brings first new US sunscreen ingredient in over 25 years

US regulators have approved bemotrizinol, the first new sunscreen ingredient cleared in more than 25 years. The Food and Drug Administration said it meets safety and effectiveness standards, offering broad UVA and UVB protection with low irritation and minimal absorption. It is approved for adults and children aged 6 months and older, with an initial US launch planned by DSM Nutritional Products.

US health regulators approved bemotrizinol, the first new sunscreen ingredient for the country in over 25 years. The Food and Drug Administration said the chemical met safety and performance rules. The agency said it protects against harmful ultraviolet rays. The FDA also said it causes little irritation and shows low skin absorption.

The FDA said bemotrizinol is safe for adults and for children aged 6 months and older. The ingredient has been used for years in Europe and other regions. It was authorised by European authorities in 1999. The ingredient was first submitted to the FDA for review in 2005.

FDA bemotrizinol approval and US sunscreen ingredient rollout

Bemotrizinol will first be sold in the US by DSM Nutritional Products. The Dutch firm plans to use the brand name Parsol Shield. The launch is expected later in the year. After an 18-month exclusivity period, other sunscreen makers can use bemotrizinol in products.

Efforts to add new sunscreen ingredients have faced long delays under the FDA system. Critics said the process was heavy on paperwork. Bemotrizinol is the first ingredient to use a faster review path. Congress authorised that streamlined process in 2020, according to the FDA.

Bemotrizinol sunscreen protection against UVA and UVB rays

Experts said bemotrizinol meets a key gap in US sunscreen options. It protects against both ultraviolet A and B rays. Specialists also said it does not leave white streaks. Those streaks are often linked to mineral-based sunscreen products used on skin.

Under FDA rules, sunscreens must block UVB rays that cause most sunburn. They also must block UVA rays linked to skin cancer risk and wrinkles. Current chemical filters in the US often cover only one type. Companies usually blend ingredients to reach broad spectrum protection.

Mineral ingredients like zinc oxide already block both UVA and UVB rays. However, they can leave a chalky white residue on skin. That look can affect how people use sunscreen. Bemotrizinol offers another approach while still meeting safety standards, the FDA said.

FDA sunscreen standards and bemotrizinol in the broader policy shift

"For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,\" said David Andrews of the Environmental Working Group. \"The approval of bemotrizinol will help change that.\" Andrews said the group has urged the FDA to allow new ingredients. The group has also called for tighter sunscreen standards.

\"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,\" said Dr. Mike Davis, acting director of FDAs drug centre. The agency said bemotrizinol met its standards for protection. It also said the ingredient caused little irritation and low absorption.

The FDA has updated sunscreen rules in recent years. In 2011, the agency barred terms like waterproof, calling them misleading. It also required that sunscreens filter UVA and UVB rays. Earlier, some formulas only protected against UVB. In 2021, the FDA proposed capping SPF and raising UVA protection, but those steps are unfinished.

With inputs from PTI