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Officials with the US FDA this week issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States
Officials with the US FDA this week issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States that aims to bring nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science, according to a press release from the Administration.
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.
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 (GRASE) and not misbranded. Over the last 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 GRASE.
In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:
The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works towards developing a final rule.
This article was originally published onPharmacyTimes.com