Updates on FDA Regulation of Over-the-Counter Sunscreen Drug Products

Posted on Behalf of  Jillian Parker, Ernest Fung

Posted on behalf of Jillian Parker and Ernest Fung


Sunscreen products are primarily regulated at the discretion of the U.S. Food and Drug Administration (FDA). In general, any over-the-counter (OTC) product that includes one or more sunscreen active ingredients, in conjunction with labeling claims that the product may be used as a sunscreen (or similar sun protection language), establishes the product’s intended use as a drug (Registrar Corp 2014). While the FDA published a final monograph entitled “Sunscreen Drug Products for Over-the-Counter Human Use” in 1999, this regulation was placed under indefinite stay due to concerns surrounding increased consumer exposure to sunscreen active ingredients, as well as the need for additional safety information (1999 Final Monograph). To exercise its enforcement discretion until a final monograph becomes effective, the FDA published a document in 2018 that provided both guidance for labeling OTC sunscreen drug products and testing requirements for broad-spectrum, sun protection factor (SPF), and water resistance claims (2018 Final Guidance). The recently enacted Sunscreen Innovation Act (SIA), however, requires the FDA to finalize and place into effect a sunscreen final monograph by November 26, 2019 (Gertner & Horowitz, 2019). In order to meet this deadline, the FDA published a proposed rule on February 26, 2019, to update and complete a final monograph for non-prescription, OTC sunscreen products. The FDA will be seeking comments on the proposed rule until May 28, 2019 (2019 Proposed Rule).

The 1999 Final Monograph established conditions under which OTC sunscreen products were considered generally recognized as safe and effective (GRASE) for use in humans and included testing procedures and labeling requirements for sunscreen products containing GRASE ingredients. According to this monograph, 16 active ingredients[1] were considered to be GRASE if included in the sunscreen product within specified concentration ranges, on the condition that the final sunscreen product provided a minimum SPF value of 2. Additionally, for sunscreen products containing a combination of two or more active ingredients, each active ingredient must contribute an SPF value of at least 2 (e.g., SPF of ≥ 4 for a product with two active ingredients). Any product that includes the term “sunscreen” on its label[2], including cosmetics, would be subject to this regulation.

The proposed rules published on February 26, 2019 state that there is not enough evidence to determine the GRASE status of twelve[3] of the active ingredients listed in the stayed 1999 Final Monograph and has proposed that these ingredients are Category III (“additional data needed”) (2019 Proposed Rule). The FDA considers only zinc oxide and titanium dioxide to be Category I (proposed to be GRASE and not misbranded) ingredients. Two compounds, aminobenzoic acid (PABA) and trolamine salicylate, would be considered Category II (proposed to be not GRASE and misbranded) ingredients, as the FDA considers the risks to human health associated with using these active ingredients in sunscreen to outweigh their benefits. Both clinical (e.g., human dermal and absorption) and non-clinical (e.g., dermal and systemic carcinogenicity, reproductive and developmental, and toxicokinetic) studies are generally needed for the FDA to determine that a sunscreen active ingredient is GRASE for use in non-prescription sunscreens. Additionally, the FDA proposed that dosage forms including oils, lotions, creams, gels, butters, pastes, ointments, sticks, and spray sunscreen are Category I, whereas all other dosage forms, such as wipes, towelettes, body washes, and shampoos, are new drugs because of the lack of historical marketing data. The FDA noted that combination sunscreen and insect repellant products would be considered a Category II formulation because of the incompatibility between FDA and EPA labeling requirements; data also suggest that combining sunscreen active ingredients with DEET, the active ingredient in insect repellant, can increase the absorption of either or both components.

Because of the short timeline, the data gaps identified for Category III ingredients are unlikely to be sufficiently addressed prior to publication of a final rule (Gertner & Horowitz, 2019). In the final rule, the FDA will either determine that the Category III ingredients are not GRASE, which will require an approved new drug application (NDA) or abbreviated new drug application (ANDA) for continued marketing, or defer rulemaking for these ingredients to allow the necessary research to be completed and evaluated. However, whether the FDA would be willing to grant deferral for ingredients that the agency considers unlikely to be GRASE based on the current data remains unclear. The proposed rules suggest that the FDA would not expect full compliance until one year after the effective date of the final rule (November 26, 2020), and that full compliance would not be expected for product units that were introduced into commerce before November 26, 2019. Additionally, while the proposed provisions are not necessarily final, sunscreen companies should familiarize themselves with the 1999 Final Monograph, required labeling, and the newly proposed rule in order to prepare for product compliance.

Cardno ChemRisk scientists have extensive professional experience evaluating the possible hazards posed by chemicals in consumer products, including sunscreens. If you would like more information on Cardno ChemRisk's capabilities or have any further questions regarding this topic, please contact Dr. Ernest Fung at ernest.fung@cardno.com or Dr. Jillian Parker at jillian.parker@cardno.com.

[1] aminobenzoic acid (PABA), avobenzone, cinoxate, dioxybenzone, homosalate, menthyl anthranilate (meradimate), octocrylene, octyl methoxycinnamate (octinoxate), octyl salicylate (octisalate), oxybenzone, padimate O, phenylbenzimidazole sulfonic acid (ensulizone), sulisobenzone, titanium dioxide, trolamine salicylate, and zinc oxide

[2] or in any other suggested that the product is intended to prevent, cure, treat, or mitigate a disease caused by exposure to the sun

[3] avobenzone, cinoxate, dioxybenzone, homosalate, menthyl anthranilate (meradimate), octocrylene, octyl methoxycinnamate (octinoxate), octyl salicylate (octisalate), oxybenzone, padimate O, phenylbenzimidazole sulfonic acid (ensulizone), and sulisobenzone