Label: NO MAKEUP BRONZER SPF15- zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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)