Label: SKIN PROTECTANT lotion

  • 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 4, 2022

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  • OTC ACTIVE INGREDIENT

    OTC Active Ingredients

  • OTC PURPOSE SECTION

    OTC Purpose

  • OTC KEEP OUT OF REACH OF CHILDREN

    OTC Keep Out Of Reach Of Children

  • ARTWORK

    Artwork

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    skin protectant lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-227
    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
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    MICA (UNII: V8A1AW0880)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    Product Characteristics
    Colorbrown (Light Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-227-4084 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)