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 December 31, 2020

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  • OTC - ACTIVE INGREDIENT SECTION

    OTC Active Ingredients

  • OTC - KEEP OUT OF REACH OF CHILDREN

    OTC Keep Out Of Reach Of Children

  • OTC - PURPOSE

    OTC Purpose

  • ARTWORK (BACK LABEL NO. 1)

    ARTWORK - BACK

  • ARTWORK (BACK LABEL NO. 2)

    ARTWORK - BACK

  • ARTWORK (FRONT LABEL)

    Artwork

  • ARTWORK (BACK LABEL NO. 3)

    ARTWORK - BACK

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-243
    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
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-243-4218 g in 1 CONTAINER; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2020
    Labeler - Private Label Select Ltd CO (005415463)