The US Food and Drug Administration (FDA) announced a proposal to use a sunscreen ingredient common in Europe in the formulation of US SPFs.
The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens in the US, as part of a broader initiative in the Office of Nonprescription Drugs.
Based on the data reviewed by the FDA, bemotrizinol is said to provide protection against both UVA and UVB rays, has low levels of absorption through the skin into the body and rarely causes skin irritation.
If the action is finalised, bemotrizinol will be an additional sunscreen active ingredient that the FDA considers to be generally recognised as safe and effective for use by adults and children six months of age and older, expanding consumer choice.
“The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad,” said FDA Commissioner Marty Makary.
“We are continuing to modernise the regulation of sunscreen and other over-the-counter drug products.
“Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available.”
The FDA regulates sunscreens to ensure they meet safety and effectiveness standards.
The move has been met with praise from the American Academy of Dermatology Association (AAD), which applauded the FDA for taking the “first steps in more than two decades to provide more safe and effective sunscreen options to the American public”.
Unprotected exposure to UV rays is a major risk factor for skin cancer, the most common cancer in America.
It is estimated that one in five Americans will develop skin cancer in their lifetime and nearly 20 Americans die from melanoma, the deadliest form of skin cancer, every day, according to the AAD.
The association said the US “lags behind many other countries that have nearly twice as many approved sunscreen ingredients”.
The AAD said in a statement: “Because dermatologists see first-hand the impact that skin cancer has on patients and their families, they recommend everyone apply sunscreen, seek shade, and wear protective clothing to protect their skin from sunburn, early skin ageing, and skin cancer.
“The academy recommends that everyone use a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher on skin not protected by clothing when outside.
“The academy has been advocating for many years for the availability of more sunscreen options for US consumers.
“The academy remains committed to supporting and enhancing patient care.”
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