Kabana Skin Care

Selected passages from the FDA letter

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

Passage 1

Your “Kabana Body Wash +UV” product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a).

Passage 2

However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.

Passage 3

Accordingly, your “Kabana Body Wash +UV” sunscreen drug product is a misbranded drug introduced or delivered for introduction into interstate commerce in violation of sections 502(ee) and 301(a) of the FD&C Act, 21 U.S.C. 352(ee) and 331(a).