Label: NO MAKEUP BRONZER SPF15- zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 10, 2023

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  • DOSAGE & ADMINISTRATION

    Dosage

  • ACTIVE INGREDIENT

    Actives

  • INACTIVE INGREDIENT

    Inactives

  • INDICATIONS & USAGE

    Indications

  • KEEP OUT OF REACH OF CHILDREN

    Children

  • PURPOSE

    Purpose

  • OTHER SAFETY INFORMATION

    Base Label

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    NO MAKEUP BRONZER SPF15 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.38 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-711-0313.9 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/03/2022
    Labeler - N.V Perricone LLC (054414243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc (DMI)076693183manufacture(45634-711)