Label: SUN SHADES 15 LIP BALM CRANBERRY TANGERINE- octinoxate and oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 30, 2010

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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 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
    SUN SHADES  15 LIP BALM CRANBERRY TANGERINE
    octinoxate and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-160
    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:54473-160-014.2 g in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2008
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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