FDA Considers Updating OTC Sunscreen Regulations

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would update regulatory requirements for most sunscreen products in the U.S. The FDA’s action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

“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, yet some of the essential requirements for these preventive tools haven’t been updated in decades,” says FDA Commissioner Scott Gottlieb, M.D. “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. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens. The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

The agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective and not misbranded. Over the past 20 years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered generally recognized as safe and effective.

Sunscreen is among the thousands of promotional products sold in the industry. In 2017 it was included in the Health product category of beauty and hygiene along with lip balm and hand sanitizer in PPAI®’s Sales Volume Study. The category was the 10th largest that year with distributor sales for the beauty and hygiene segment alone estimated at almost $303 million.

For more on the FDA’s proposals for sunscreens marketed without FDA-approved applications, click here. The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works towards developing a final rule.

filed under February 2019
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