Label: BABY MINERAL SUNSCREEN, SPF 30- 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 January 1, 2021

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  • OTC - Active Ingredient

    OTC Active Ingredients

  • OTC - Purpose

    OTC Purpose

  • Dosage & Administration

    Dosage and Administration

  • Inactive Ingredient Section

    Inactive Ingredients

  • Indications & Usage

    Indications and Usage

  • Warnings Section

    Warnings Section

  • Artwork

    Artwork

  • INGREDIENTS AND APPEARANCE
    BABY MINERAL SUNSCREEN, SPF 30 
    sunscreen ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-259
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-259-4689 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)
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