Label: TINTED SUNSCREEN- tinted 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 30, 2020

If you are a consumer or patient please visit this version.

  • 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 (FRONT)

    Artwork

  • ARTWORK (BACK)

    Artwork

  • INGREDIENTS AND APPEARANCE
    TINTED SUNSCREEN 
    tinted zinc oxide sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-240
    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
    WHITE WAX (UNII: 7G1J5DA97F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-240-3414 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)