Proposed rule details
The proposal targets nonprescription, OTC sunscreens that do not require FDA approval to be sold in the United States. FDA said the proposed rule aims to ensure such sunscreens are "up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options."
The proposed rule stated that, of the 16 main chemical ingredients currently used to make OTC sunscreen products, just two ingredients—zinc oxide and titanium dioxide—meet FDA's standards for being generally recognized as safe and effective (GRASE). Substances made from GRASE ingredients do not need FDA's approval before they can be sold OTC.
FDA in the proposed rule noted that two additional ingredients typically found in OTC sunscreen, PABA and trolamine salicylate, are not considered GRASE because of safety issues, and the remaining 12 ingredients do not have sufficient safety data for FDA to determine whether they are GRASE. As such, FDA in the proposed rule called on industry and other stakeholders to supply the agency with additional data on those 12 ingredients.
FDA in the proposed rule also highlighted several forms of OTC sunscreen that should not be considered GRASE, including body washes, shampoos, towelettes, wipes, and products that combine sunscreen with insect repellents. FDA said it needs additional data to determine whether OTC sunscreen powders are GRASE.
FDA also proposed increasing the maximum sun protection factor (SPF) that is permitted on OTC sunscreen labels from SPF 50+ to SPF 60+. In addition, FDA proposed requiring any OTC sunscreens with an SPF 15 value or higher "to also provide broad spectrum protection," and that "the magnitude of protection against UVA radiation increases" as products' SPF values increase.
FDA also proposed that manufacturers list OTC sunscreen products' ingredients on the front of the products' labels. Under the proposed rule, FDA said manufacturers must include "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."
The proposed rule also would clarify FDA's record keeping and testing requirements for entities that test sunscreens.
FDA is accepting public comments on the proposed rule for 90 days.
FDA Commissioner Scott Gottlieb said, "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." He called the proposed rule "an important step in … FDA's ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens."
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "It is important that, as this rulemaking effort moves forward and … 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."
FDA said OTC sunscreen products currently on the market will continue to be available while the rulemaking process proceeds (Maddipatla, Reuters, 2/21; FDA release, 2/21; Bracho-Sanchez, CNN, 2/21; NBC News, 2/21).
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