Label: LIP BALM- spf18 lip balm 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 May 14, 2018

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  • PRINCIPAL DISPLAY PANEL

    Lip Balm Tube Label

  • PRINCIPAL DISPLAY PANEL

    Lip Balm Carton

  • INGREDIENTS AND APPEARANCE
    LIP BALM 
    spf18 lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-166
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)  
    RED CURRANT (UNII: Q5YG47WU3D)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    WHITE CURRANT (UNII: H415EVM0YK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorFRUIT (Grapefruit Currant) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-166-251 in 1 CARTON05/14/2018
    14.2 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/14/2018
    Labeler - Private Label Select Ltd CO (005415463)
    Registrant - Private Label Select Ltd CO (005415463)
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