Label: SPF 15 LIP BALM KEY LIME 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 31, 2020

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  • OTC - ACTIVE INGREDIENT

    OTC Active Ingredients

  • OTC - PURPOSE

    OTC Purpose

  • ARTWORK

    Artwork

  • INGREDIENTS AND APPEARANCE
    SPF 15 LIP BALM KEY LIME 
    spf 15 lip balm key lime stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-244
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorLIME (KEY LIME) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-244-384.2 g in 1 CONTAINER; 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)
    Registrant - Private Label Select Ltd CO (005415463)
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