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FDA Proposes Updated Requirements for Sunscreen Products

By: Hillary Ojeda
Posted: Monday, March 4, 2019

The U.S. Food and Drug Administration (FDA) recently announced a proposal to update its regulations for over-the-counter sunscreen products in the United States. The rule would require the FDA to use new conditions under which the agency would allow products to be marketed without approved drug applications after being generally recognized as safe and effective.

“[This] 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,” said FDA Commissioner Scott Gottlieb, MD, in a news release.

The rule requires the FDA to use over-the-counter monographs, which establish seven conditions under which the agency would permit the products to be marketed. By implementing the proposal, the FDA would use the regulations required by the Sunscreen Innovation Act. The conditions cover ingredients, dosage forms, and the maximum proposed sun protection factor value (from 50+ to 60+), among other items. In addition, it proposes the inclusion of active ingredients on the front of the product’s packaging and that products combining sunscreens with insect repellents not be generally recognized as safe and effective.

“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,” said Dr. Gottlieb.

The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works toward developing a final rule.

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