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 February 1, 2020

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  • Dosage and Administration

    Dosage and Administration

  • Warnings Section Part 1

    Warnings Part One

  • Warnings Section Part Two

    Warnings Section Part Two

  • Inactive Ingredients

    Inactive Ingredients

  • Indications and Usage

    Indications and Usage

  • OTC Purpose Section

    OTC Purpose Section

  • OTC Active Ingredient Section

    OTC Active Ingredients

  • OTC- Keep Out of Reach of Children

    Keep out of reach of children

  • Front Label

    Front Label

  • Back Label

    Back Label

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-214
    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
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MICA (UNII: V8A1AW0880)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Product Characteristics
    Colorbrown (Light Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-214-3314 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)