Label: SUN SHADES LIP BALM- 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 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:  Octinoxate 7.5% w/w, Oxybenzone 3% w/w.

  • PURPOSE

    Uses:  Helps protect against sunburn.

  • WARNINGS

    Warnings:  Keep out of eyes.  Stop use if skin rash/irritation occurs.  Keep out of reach of children.

  • WHEN USING

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

  • INACTIVE INGREDIENT

    Inactive 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

    image of label

  • INGREDIENTS AND APPEARANCE
    SUN SHADES LIP BALM   POMEGRANATE SPF 15
    octinoxate and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-168
    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
    Petrolatum (UNII: 4T6H12BN9U)  
    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)  
    Glycyrrhizin, Ammoniated (UNII: 3VRD35U26C)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPOMEGRANATE (Pomegranate) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-168-014.2 g in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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