On September 14, 2011, the Food and Drug Administration (FDA) announced that it is extending the comment period for the Advance Notice of Proposed Rulemaking (ANPR) regarding over-the-counter (OTC) sunscreen products that the FDA currently considers potentially eligible for inclusion in the OTC sunscreen monograph (i.e., oils, lotions, creams, gels, butters, pastes, ointments, sticks and sprays). The comment period for this ANPR, which was originally set to end on September 15, 2011, is now extended until October 17, 2011. The notice of this extension is available by clicking here.1
The FDA may eliminate spray sunscreens from the OTC Drug Review Program if questions relating to their safety and effectiveness are not resolved. The FDA is requesting additional data sufficient to support appropriate monograph conditions (e.g., testing and labeling specific to sprays) for spray sunscreens to be included in the future final sunscreen monograph. The FDA believes existing data does not adequately support the safety and effectiveness of spray sunscreens because:
- Sprays are dispensed in a more diffuse manner than creams and lotions;
- The amount of dispensed spray that is effectively transferred to the skin is unclear; and
- It is hard to tell if coverage provided is uniform.
In the original ANPR released on June 17, 2011, the FDA stated its view that sunscreens formulated or dispensed as wipes, towelettes, powders, body washes and shampoos are already not eligible for review under the OTC monograph system and would require approval as new drugs. The FDA could find no evidence that these dosage forms were marketed as OTC sunscreen drugs before the OTC Drug Review program began. For additional information regarding the original ANPR published on June 17, 2011, please click here.2