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Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.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 recognizes the need for modernization of USP monographs. CHPA member companies are dedicated to fulfilling their commitment outlined in the letter to this Planning Committee on February 2, 2011.
CHPA strongly supports the unanimous votes by the advisory committees to add weight-based dosing directions to the existing age-based labeled dosing directions for children.