Label: LIP BALM- sunscreen 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 November 17, 2018

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  • Napa Soap Lip Balm SPF15

    Napa Soap Lip Balm SPF15

  • INGREDIENTS AND APPEARANCE
    LIP BALM 
    sunscreen lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    RESVERATROL (UNII: Q369O8926L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-177-254.25 g in 1 TUBE; Type 0: Not a Combination Product11/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/19/2018
    Labeler - Private Label Select Ltd CO (005415463)
    Registrant - Private Label Select Ltd CO (005415463)