Label: NO MAKEUP BRONZER SPF15- zinc oxide liquid
- NDC Code(s): 45634-711-03
- Packager: N.V Perricone LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated July 10, 2023
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INGREDIENTS AND APPEARANCE
NO MAKEUP BRONZER SPF15
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45634-711 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.38 g in 10 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C) ISODODECANE (UNII: A8289P68Y2) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYL FERULATE (UNII: 5B8915UELW) PROPYLENE CARBONATE (UNII: 8D08K3S51E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FERROUS OXIDE (UNII: G7036X8B5H) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM CITRATE (UNII: 1Q73Q2JULR) XYLITOL (UNII: VCQ006KQ1E) CAPRYLIC ACID (UNII: OBL58JN025) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) MICA (UNII: V8A1AW0880) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MALTODEXTRIN (UNII: 7CVR7L4A2D) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALPINIA OFFICINARUM LEAF (UNII: 8584IDD6OR) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45634-711-03 13.9 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/03/2022 Labeler - N.V Perricone LLC (054414243) Establishment Name Address ID/FEI Business Operations Dimensional Merchandising Inc (DMI) 076693183 manufacture(45634-711)