Label: SUNSCREEN- zinc oxide sunscreen stick

  • 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 March 20, 2020

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  • OTC-Active Ingredients

    Active Ingredients

  • Dosage and Administration

    Dosage & Administration

  • Inactive Ingredients

    Inactive Ingredients

  • Indications & Usage

    Indications & Usage

  • OTC-Purpose

    Purpose

  • Warnings PART 1

    Warnings Part One

  • Warnings Part Two

    Warnings Part Two

  • OTC Keep out of reach of children

    OTC Keep out of reach of children

  • Back Label

    Back Label

  • Front Label

    Front Label

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    Product Characteristics
    Colorbrown (Medium Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-215-3314 g in 1 CONTAINER; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2020
    Labeler - Private Label Select Ltd CO (005415463)