On February 21, 2019, the U.S. Food and Drug Administration released a proposed rule that would update regulatory requirements for most sunscreen products in the United States. The new rule includes several changes aimed at increasing safety and efficacy of nonprescription, over-the-counter (OTC) sunscreens. The proposal addresses sunscreen active ingredient safety and dosage, 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 FDA is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act.
The proposed changes, which pertain to sunscreens that can be marketed without FDA-approved applications, include:
- Of the 16 currently marketed active ingredients, two ingredients—zinc oxide and titanium dioxide—are GRASE (generally recognized as safe and effective) for use in sunscreens; two ingredients—PABA and trolamine salicylate—are not GRASE for use in sunscreens due to safety issues. The FDA notes that there are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. It is asking industry and other interested parties for additional data and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data.
- A proposal that dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks. Powders are proposed to be eligible for inclusion in the monograph, but the FDA is requesting additional data before powders can be included in the monograph. Wipes, towelettes, body washes, shampoos and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph.
- Raising the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+
- Requiring sunscreens with an SPF value of 15 or higher to also provide broad-spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases
- New sunscreen product label requirements to assist consumers in more easily identifying key information, including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum and water resistance statements
- Clarification of the FDA’s expectations for testing and record keeping by entities that conduct sunscreen testing to ensure that the FDA can assess industry compliance with regulations
- Products that combine sunscreens with insect repellents are not GRASE
“It is important that, as this rulemaking effort moves forward and the FDA gathers additional scientific information, given the recognized public health benefits of sunscreen use, consumers continue to use sunscreen in conjunction with other sun-protection measures,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises.”
The FDA is seeking public comment on the proposed rule and will consider comments provided as the agency works towards developing a final rule.
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