SUNSHADES 15 LIP BALM HARVEST BERRY (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.]

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SUNSHADES 15 LIP BALM HARVEST BERRY (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.]
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NDC 54473-137-01
Set ID dab92afa-cb94-44bb-8353-b622b0ac44b0
Category HUMAN OTC DRUG LABEL
Packager Melaleuca, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • DOSAGE & ADMINISTRATION

    Directions:  Apply to the lips prior to sun exposure or as needed.

  • WARNINGS

    Caution:  For external use only.  Keep out of reach of children.  If irritation or rash develops discontinue use.  Avoid contact with the eyes.

  • ACTIVE INGREDIENT

    Active Ingredients:  Octinoxate 7.5% w/w.  Oxybenzone 3.0% w/w.

  • INACTIVE INGREDIENT

    Other Ingredients:  Petrolatum USP, Jojoba Oil, Beeswax, Cetyl Esters, Ozokerite, Cocoa Butter, Stearyl Dimethicone, Flavor, Tocopheryl Acetate (Vitamin E USP), Monoammonium Glycyrrhizinate, Ethylene VA Copolymer.

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    SUNSHADES  15 LIP BALM HARVEST BERRY
    octinoxate and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-137
    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) Oxybenzone30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Jojoba Oil (UNII: 724GKU717M)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Cetyl Esters Wax (UNII: D072FFP9GU)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Cocoa Butter (UNII: 512OYT1CRR)  
    VITAMIN E ACETATE (UNII: 9E8X80D2L0)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-137-014.2 g in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2006
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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