FDA seeks to update sunscreen requirements

FDA is tightening up rules to make OTC sunscreen products more safe and effective. On February 21, FDA announced a proposed rule that would update regulatory requirements for sunscreens sold in the United States.

Among the proposals for sunscreens that are marketed without FDA-approved applications, FDA is seeking to gather information and assess the safety of active chemical ingredients in sunscreens; cap high SPF claims at 60+ instead of 50+; require improvement to broad-spectrum and ultraviolet A (UVA) protection; call for more consumer-friendly product labels so that key active ingredients are more easily identifiable; and ban insect repellents in sunscreens products.

“Broad-spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” said FDA Commissioner Scott Gottlieb, MD, in a written statement. “Yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts,” he said.

Current recommendations urge consumers to purchase sunscreen products that are broad spectrum, meaning they can protect against both long-wave UVA and short-wave ultraviolet B rays to help prevent skin cancer and sunburn. As a result of a 2011 FDA ruling, labels on sunscreen products must provide consumers with information about the type of ultraviolet protection in the product and what it can do.

FDA is seeking public comment on the proposed rule as the agency works toward developing a final rule.