Daijiworld Media Network – Washington

Washington, Jun 10: The US Food and Drug Administration (FDA) has approved the first new sunscreen ingredient for the American market in more than 25 years, paving the way for wider access to a skin-protecting compound that has been used in Europe and several other countries for decades.

The newly approved ingredient, bemotrizinol, was found to meet the FDA's standards for protection against harmful ultraviolet (UV) radiation while causing minimal skin irritation and limited absorption into the body. The agency said the ingredient is safe for use by adults and children aged six months and older.

Bemotrizinol will initially be marketed in the United States by Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, with commercial availability expected later this year.

Under the approval terms, DSM will enjoy an 18-month exclusivity period before other sunscreen manufacturers can incorporate the ingredient into their products.

The approval marks a significant milestone for the US sunscreen industry, where efforts to introduce new UV-filtering ingredients have faced regulatory hurdles for decades.

Bemotrizinol is the first sunscreen ingredient to be cleared through a streamlined review process established by the US Congress in 2020.

Experts say the ingredient offers an important advantage because it protects against both UVA and UVB rays.

While UVB rays are primarily responsible for sunburn, UVA rays are more closely linked to skin ageing, wrinkles and skin cancer risk.

Most existing chemical sunscreen ingredients available in the United States provide protection against either UVA or UVB radiation, requiring manufacturers to combine multiple ingredients to achieve broad-spectrum coverage.

Mineral-based sunscreens containing zinc oxide can block both types of rays but often leave a visible white residue on the skin.

Health advocates welcomed the approval, noting that bemotrizinol has been widely used internationally for more than two decades.

The ingredient was first approved in Europe in 1999 and was submitted to the FDA for review in 2005.

FDA officials said the agency remains committed to ensuring consumers have access to safe and effective over-the-counter products, including sunscreens.

The approval is part of broader efforts by the FDA to modernise sunscreen regulations.

In recent years, the agency has introduced stricter labelling requirements, including banning the use of terms such as "waterproof" and mandating that sunscreens provide protection against both UVA and UVB rays.

Additional proposals under consideration include stronger UVA protection standards and limits on the use of very high SPF claims.

The approval of bemotrizinol is expected to expand consumer choice and provide manufacturers with a new option for developing advanced broad-spectrum sunscreen products.