Label: SUNSCREEN- zinc oxide sunscreen ointment

  • 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 Purpose Section

    OTC Purpose

  • OTC Active Ingredient Section

    OTC Active Ingredients

  • OTC- Keep Out of Reach of Children

    OTC Keep Out Of Reach Of Children

  • ARTWORK (SQZ TUBE)

    Artwork

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide sunscreen ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-246
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    MICA (UNII: V8A1AW0880)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    Product Characteristics
    Colorbrown (Light Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-246-4185 g in 1 TUBE; 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)