FDA Issues Proposed Rule for Sunscreen

Laurie Barclay, MD

August 29, 2007 — The US Food and Drug Administration (FDA) is issuing a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of the FDA's ongoing review of OTC drug products. The proposed rule, which is published in the August 27 issue of the Federal Register, addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection.
Written or electronic comments concerning this proposed rule should be submitted to the FDA by November 26, 2007.
Proposed changes to the final monograph are as follows:
A. Ingredients: Permitted combinations of active sunscreen ingredients would include avobenzone with zinc oxide and avobenzone with ensulizole.
B. UVB (Sun Protection Factor [SPF]) Labeling: Specific labeled SPF values would be permitted up to, but not exceeding, an SPF of 50. OTC sunscreen drug products with SPF values greater than 50 would be labeled with the collective term "50+." The phrase "sun protection" would be changed to "sunburn protection." The term "UVB" would be included before the term "SPF" on the principal display panel (PDP), along with the product category designation (PCD). The PCD SPF ranges would reflect the current standard public health message concerning use of sunscreens. The current category descriptors of "minimal" and "moderate" would be replaced with the terms "low" and "medium," respectively.
C. UVA Labeling: The new labeling would designate the level of UVA protection on the PDP of OTC sunscreen drug products, using stars with a descriptor ("low," "medium," "high," or "highest").
D. Indications: There would be an additional indication regarding UVA protection involving selection of the appropriate descriptor ("low," "medium," "high," or "highest") to describe the level of protection.
E. Warnings: "Stop use and ask a doctor if...rash or irritation develops and lasts" would be changed to "if...skin rash occurs." A revised "sun alert" statement would be required on all OTC sunscreen drug products except lip cosmetic–drug and lip protectant–sunscreen products. This statement would read: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen."
F. Directions: The proposed changes should reduce the likelihood that OTC sunscreen drug products will be underapplied. One of 2 terms would be required ("liberally" or "generously"), and the word "evenly" would be included as an additional optional term. A new direction would be added: "apply and reapply as directed to avoid lowering protection."
G. UVB Testing: A padimate O/oxybenzone sunscreen standard would be required for testing sunscreen products with SPF values over 15. This padimate O/oxybenzone standard or the homosalate standard would be used to test products with SPF values of 2 to 15. A high-pressure liquid chromatography method would replace the spectrophotometric method used to assay the homosalate and padimate O/oxybenzone standards.
H. UVA Testing: A combination of spectrophotometric (in vitro) and clinical (in vivo) UVA test procedures would be used. For "water resistant" and "very water resistant" sunscreen products, the in vivo UVA test would be performed after the appropriate water immersion period for OTC sunscreen drug products.
"FDA is issuing this proposed rule after considering public comments and new data and information that have come to FDA's attention," the authors write. "FDA understands the seasonal nature of the sunscreen industry and the time required for product testing and relabeling. FDA is also aware that more than 1 year may be needed for implementation."
Fed Reg. 2007;72:49070–49122.