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FDA unveils proposed changes to OTC sunscreen labeling, active ingredients

Posted 24 September 2021 | By Mary Ellen Schneider 

FDA unveils proposed changes to OTC sunscreen labeling, active ingredients

The US Food and Drug Administration (FDA) is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.
The proposed order, which was announced on 24 September 2021 and has a 45-day public comment period, closely follows the agency’s 2019 proposed rule on sunscreens. It also includes changes related to the maximum sun protection factor (SPF) labeling, dosage forms considered GRASE, and sunscreen-insect repellent combinations. (RELATED: FDA proposes new rule for sunscreen products, Regulatory Focus 21 February 2019)
The new proposed order on sunscreen products “is an important step in FDA’s effort to follow the latest science,” Therese Michele, director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said during a press conference to announce the regulatory changes.
Along with the proposal, the FDA also issued a deemed final order, which is required under the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. The deemed final order incorporates requirements on sunscreen active ingredients from a 1999 final monograph regulation for OTC sunscreen products, which never went into effect, as well as labeling and effectiveness requirements from a 2011 final rule. Most sunscreens on the market are already in compliance with the deemed final order, according to FDA, so it keeps the status quo in place.
In addition to the deemed final order, the CARES Act changed FDA’s rulemaking process for OTC monograph drugs, such as sunscreen. The new administrative order process is aimed at allowing FDA to revise OTC monographs more expeditiously as science evolves or safety signals emerge, Michele said.  
Proposed labeling changes
Among the labeling changes suggested in the proposed order is that the maximum labeled SPF should be SPF 60+, though products can be formulated with SPF values up to 80. The deemed final order does not include an upper limit on SPF values.
The agency is also proposing to add more information to the main part of the sunscreen label, including an alphabetical list of the active ingredients, followed by the dosage form (such as lotion or spray). Sunscreen products that have not been shown to help prevent skin cancer or early skin aging from the sun will need to include an asterisk on the main label directing consumers to a “Skin Cancer/Skin Aging alert” on another part of the product label. These changes were informed by research into consumer behavior that showed that many people do not read the Drug Facts section of the sunscreen label.
Broad spectrum requirements
The proposed order also includes a requirement that all sunscreens with SPF values of 15 and above provide broad spectrum sun protection at a ratio of ultraviolet (UV) A1/UV of 0.7 or higher. This proposal is based on the growing evidence of significant harms associated with UVA exposure, according to the FDA.
Active ingredients and dosage forms
Certain OTC drug products are allowed to be marketed without a new drug application if they are considered GRASE by the FDA. In this latest sunscreen proposal, the FDA seeks to change the GRASE status for sunscreen active ingredients. Currently, sunscreen products can be considered GRASE if they contain any of 16 active ingredients. Under the proposal, FDA is trimming this list and deeming only certain ingredients to be GRASE. The proposal would grant GRASE status for sunscreens containing zinc oxide and titanium dioxide. The agency proposed that sunscreens with aminobenzoic acid (PABA) and trolamine salicylate would not be given GRASE status due to safety concerns.
The agency’s evaluation of safety data related to PABA and trolamine salicylate concluded that the risks outweigh the benefits for products with those ingredients, though neither ingredient is currently used in marketed sunscreens, according to the FDA. The risks for trolamine salicylate include serious bleeding, vomiting, hyperventilation, metabolic disturbances, coma, and even death. PABA risks include allergic and photoallergic skin reactions. 
The agency is seeking additional data on several ingredients: cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The agency is proposing that these ingredients would not be deemed GRASE until additional data are submitted to show they qualify for this status.
“If at the close of the comment period on this proposed order, the available data do not resolve the outstanding questions about each of these ingredients, but the agency has received satisfactory indication of timely and diligent progress on the necessary studies for a specific ingredient, FDA would be prepared to initially defer issuance of a revised final order on the GRASE status of sunscreens containing that particular active ingredient,” the agency wrote in a questions and answers document explaining the new regulatory actions. “Such a deferral would be for a period of not more than one year, with a possibility of extension depending on further satisfactory progress with the studies.”
Sunscreen-insect repellent combinations were also deemed as not GRASE by the FDA under the proposed order.
Similarly, the FDA proposed changes to the GRASE status of certain sunscreen dosage forms. Under the proposal, GRASE status would be granted to oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Sprays would be deemed GRASE subject to testing and labeling requirements and more data is needed to decide on powders, according to the FDA.
Record keeping requirements
The proposed order also includes new record-keeping and maintenance requirements for sunscreen product manufacturers. The proposal would mandate that records of required final formulation testing of sunscreen products be maintained for one year after the product’s expiration date, or, if it is exempt from expiration dating, three years after distribution of the last lot labeled. The FDA is also proposing new record-keeping on sunscreen formulation testing that would be subject to agency inspection.
Deemed Final Order
2021 Proposed Order


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