Label: ZINC OXIDE LIP BALM PINA COLADA 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 SECTION

    OTC Purpose

  • OTC - KEEP OUT OF REACH OF CHILDREN

    OTC Keep Out Of Reach Of Children

  • ARTWORK

    Artwork

  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE LIP BALM PINA COLADA 
    zinc oxide lip balm pina colada stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-249
    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
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPINEAPPLE (Pina-colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-249-384.25 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)