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 29, 2020

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  • OTC - ACTIVE INGREDIENT SECTION

    OTC ACTIVE

  • OTC- KEEP OUT OF REACH OF CHILDREN

    OTC Keep Out Of Reach Of Children

  • OTC-PURPOSE

    OTC Purpose

  • ARTWORK - FRONT LABEL

    Artwork - FRONT

  • ARTWORK - BACK LABEL

    Artwork - BACK LABEL

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-230
    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
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-230-4218 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)
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