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M & M Beauty and Wellness, LLC distributed "BEST age spot remover lightening perfection crème," an unapproved new drug containing 2% hydroquinone that was intended for skin bleaching and lightening age spots, in violation of section 505(a) of the Federal Food, Drug & Cosmetic Act. The product was also misbranded under section 502(ee) of the FD&C Act because it lacked required FDA approval before being introduced into interstate commerce. The company made drug claims on the product label and website describing its skin-lightening uses, which established the product's intended use as a drug requiring pre-market approval.