Waxhead Sun Defense Company

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 2

To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a shampoo or face/body wash dosage form.

Passage 3

There are no provisions in any of the respective categories’ monographs, nor any monograph, that allow for a combination sunscreen, antifungal, control of dandruff and psoriasis, and acne drug product.