On Monday, August 27, 2007, FDA issued a proposed rule to amend the OTC monograph for sunscreen products. A final monograph was issued in 1999 at 21 C.F.R. Part 352, but has been stayed since 2001. This most recent rulemaking proposes several changes to the sunscreen monograph and, when finalized, would lift the stays of 21 CFR Part 352 and 21 CFR § 347.20, which covers sunscreen-skin protectant combination products.

The proposed rule contains several significant changes to the sunscreen monograph, including the following:

1. Ingredients: FDA will permit the combinations of avobenzone (up to 3%) with zinc oxide (up to 25%) and avobenzone (up to 3%) with ensulizole (up to 4%). Companies may market OTC sunscreen products containing these combinations only after FDA has evaluated the comments and published a Federal Register notice announcing its decision to permit the marketing of such products.
2. UVB (SPF) and UVA Labeling: FDA proposes several labeling changes for UVB protection, as well as mandates new labeling to designate the level of UVA protection. With respect to UVB labeling, FDA will increase the specific labeled SPF values from 30 to 50 and revise the collective term from “30+” to “50+”. Values higher than SPF 50, however, are not permitted. Companies must insert descriptive terms of relative sunburn protection (e.g., “low,” “medium,” “high,” and “highest”) with the SPF value on the principal display panel (“PDP”). In addition, companies must insert the term “UVB” before the SPF value to differentiate the SPF value from the UVA symbol/descriptor on the PDP.
   
   FDA also will require new labeling to designate the level of UVA protection on the PDP of OTC sunscreen drug products. FDA proposes the use of symbols (“stars”) to rate the level of UVA protection from “low” (one star) to “highest” (four stars), in conjunction with a descriptor (e.g., “low,” “medium,” “high,” or “highest”). The term “UVA” must precede all four stars and the appropriate category descriptor must appear after the stars (e.g., UVA High). Companies must label sunscreen products that do not provide any UVA protection with the statement, “No UVA Protection”, near the SPF value.
3. Indications: FDA proposes several changes to the “Uses” statement. The indication currently required, “helps prevent sunburn”, will be revised to one of the following, which FDA will require on all sunscreens: “low UVB sunburn protection,” “medium UVB sunburn protection, “high UVB sunburn protection,” and “highest UVB sunburn protection”. The relative level of sunburn protection will be determined from the SPF value in accordance with the following:

   low = SPF 2 to under 15
   medium = SPF 15 to under 30
   high = SPF 30 to 50
   highest – SPF over 50

4. Warnings: FDA will revise several of the warnings currently required under the monograph. For example, FDA will require that the following “Warnings” statement appear in the Drug Facts box: “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.” This statement must appear on all OTC sunscreen drug products, except lip cosmetic-drug and lip protectant-sunscreen products.
5. Directions: FDA proposes several changes to the directions. For example, FDA will require companies to insert a new direction – “apply and reapply as directed to avoid lowering protection”.
6. UVB and UVA Testing: FDA revised the UVB and UVA testing procedures.
7. Makeup that Contains Sunscreen: FDA has clarified that it will require a “Drug Facts” box on all products containing sunscreen, including makeup that contains sunscreen, unless the product is intended for use in a small area of the face (e.g., eyes or lips) and the product is too small to include the “Drug Facts” label.

In addition to the provisions discussed above, FDA specifically seeks comments and data on sunscreen ingredients, such as titanium dioxide and zinc oxide, which are formulated in particle sizes as small as a few nanometers. FDA also seeks comments and data concerning products that contain these ingredients, their safety and effectiveness, and how they should be regulated.

Interested stakeholders have until November 26, 2007 to submit comments to FDA on the proposed rule. FDA will then review these comments and issue a final rule. The agency has indicated it expects a final rule will take effect 18 months after its publication, and two years after its publication for products with annual sales of less than $25,000. According to the proposed rule, FDA will attempt to issue the final rule to take effect in June/July, the period during which sunscreen product manufacturing for the following season generally begins.

The proposed rule may be accessed at GPOaccess.gov

If you are interested in additional information on the proposed rule, or would like to submit comments, please contact Georgia Ravitz, Marsha Wertzberger, Julie Tierney, or Amy Swift.