FDA Proposed Regulation Regarding OTC Sunscreen Monograph

FDA Proposed Regulation Regarding OTC Sunscreen Monograph

An additional proposed rule was issued on February 26th, 2019 by the United States Food and Drug Administration as they work towards finalizing a monograph for non-prescription, over-the-counter (OTC) sunscreen drug products. The efforts are aimed towards ensuring consumers have access to safe and effective sunscreen products based on the latest findings in science. The proposal focuses on the following:

Sunscreen Active Ingredient Safety

There are 16 active ingredients currently marketed in sunscreens. Zinc oxide and titanium dioxide are proposed to be generally recognized as safe and effective (GRASE). However, Para-aminobenzoic acid (PABA) and trolamine salicylate are proposed to be found unsafe and will not be permitted for use in sunscreens. According to the FDA, the remaining 12 active ingredients do not have enough clinical data to support whether they are GRASE or not. The FDA is seeking additional data from industry regarding these ingredients and is mainly focused on addressing potential long-term effects of the active ingredients, such as carcinogenicity and reproductive health.

Dosage Forms

Sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are proposed to be dosage forms that are GRASE for sunscreen use. Powders are proposed to be GRASE as a sunscreen dosage form, however, is subject to restrictions on particle size to minimize potential risks from unintended inhalation. Other dosage forms, such as body washes and shampoos, are proposed to be categorized as new drugs because of the lack of data received from the FDA regarding inclusion eligibility in the monograph.

Sun Protection Factor (SPF) and Broad-Spectrum Requirements

The proposed maximum SPF value on sunscreen labels of 50+ is proposed to be increased to 60+. The FDA is proposing that for products with SPF of 15 or higher, broad spectrum protection be provided, and increases accordingly in magnitude as SPF increases.

Labelling Requirements

FDA proposes that a statement be present on the front label to prompt consumers to read the sunscreen alert for skin cancer and skin aging that have not been shown to help in preventing skin cancer. Products that combine sunscreens with insect repellents are proposed to not be GRASE.

Electronic or written comments on the sunscreen monograph proposed rule for a can be submitted by May 28th, 2019. For the full FDA press release on this topic, please visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631736.htm

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical DevicesNatural Health ProductsOTC DrugsCosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.