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Skin PS Brands distributed Dark Spot Fix, an unapproved new drug product containing 2% hydroquinone intended for skin bleaching and lightening dark spots, in violation of FDA regulations requiring pre-market approval for new drugs. The product was misbranded because it carried drug claims on its label and website stating it would fade freckles, age spots, and liver spots, thereby establishing intended use as a drug without FDA authorization. The company marketed the product for interstate commerce through its website (slmdskincare.com) without obtaining the required new drug application approval under section 505(a) of the FD&C Act.