SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [HUMPHREYLINE]

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SUNSCREEN (OCTINOXATE, OXYBENZONE) LIPSTICK [HUMPHREYLINE]
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NDC 19392-300-01
Set ID 6e460d2c-d02f-4f19-b124-d8346e6617c1
Category HUMAN OTC DRUG LABEL
Packager Humphreyline
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Octinoxate (7.5%)

    Oxybenzone (4%)

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn and chapped lips

  • INACTIVE INGREDIENT

    Petrolatum, Octyl Palmitate, Beeswax, Paraffin, Mineral Oil, Ceresin, Cetyl Alcohol, Fragrance, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Propylparaben

  • PRINCIPAL DISPLAY PANEL

    lip balm

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:19392-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTROPICAL FRUIT PUNCH (tropical flavor) , SPEARMINT (spearmint flavor) , BUBBLE GUM (bubble gum flavor) , VANILLA (vanilla flavor) , CHERRY (cherry flavor) , STRAWBERRY (strawberry flavor) , BERRY (berry flavor) , WATERMELON (watermelon flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:19392-300-014 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2010
    Labeler - Humphreyline (122539042)
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