Sunscreen

The following comments address 1) data and information on sunscreen spray dosage forms to confirm their eligibility for inclusion in the final sunscreen monograph and 2) data and information supporting the inclusion of powder sunscreens in the final monograph.

We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.

Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.

Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.

CHPA applauds the approach for creating a public forum to collect current research and comments to advance the science of engineered nanomaterials.

The PCPC and CHPA are pleased to provide these comments in response to FDA's proposed amendment to the final monograph for OTC sunscreen drug products for human use.

CTFA and CHPA support regulatory action that allows industry to develop and market additional safe and efficacious sunscreen products.

This Citizen Petition requests the Commissioner of Food and Drugs to take the following action with respect to the Final Monograph for OTC Sunscreen Drug Products.