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 July 16, 2020

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  • ACTIVE INGREDIENTS

    ACTIVE INGREDIENTS

  • DOSAGE AND ADMIN.

    Dosage and Administration

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • OTC- KEEP OUT OF REACH

    OTC KEEP OUT OF REACH

  • OTC-PURPOSE

    PUPOSE

  • INDICATIONS AND USAGE

    Indications and Usage

  • WARNINGS SECTION

    WARNINGS

  • 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:62932-219
    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
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    Product Characteristics
    Colorbrown (Light Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-219-2646 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)
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