Label: TINTED MINERAL SUNSCREEN, SPF 30 MEDIUM TINT- 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, 2021

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  • OTC - Active Section

    OTC Active Ingredients

  • OTC - Purpose

    OTC Purpose

  • Dosage & Administration

    Dosage and Administration

  • Inactive Ingredients

    Inactive Ingredients

  • Indications and Usage

    Indications and Usage

  • Warnings

    Warnings Section

  • Artwork

    Artwork

  • INGREDIENTS AND APPEARANCE
    TINTED MINERAL SUNSCREEN, SPF 30 MEDIUM TINT 
    sunscreen ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-262
    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
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MICA (UNII: V8A1AW0880)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    Product Characteristics
    Colorbrown (Medium Tint) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-262-4689 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2021
    Labeler - Private Label Select Ltd CO (005415463)