Label: LIP BALM- octinoxate oxybenzone dimethicone lipstick

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 12, 2010

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  • Active Ingredient

    Octyl Methoxycinnamate 6%

    Oxybenzone 6%

    Dimethicone 1%



  • Purpose

    Sunscreen
    Skin Protectant

  • Uses

    • Helps prevent sunburn
    • Temporarily protects and relieves chapped lips
  • Warnings

    • Keep out of eyes. Stop use if rash or irritation occurs. Keep out of reach of children. For external use only.

  • Directions

    • Apply liberally before sun exposure and as needed.
  • Inactive Ingredients

    BHA, BHT, Caprylic/Capric Triglyceride, Cera Microcristallina, Flavor, Lanolin, Mineral Oil (Paraffinum Liquidum), Ozokerite, Petrolatum, Phenyl Trimethicone, Polyethylene, Propylparaben, PVP/Eicosene Copolymer, Tocopheryl Acetate
  • Package Label

    Package Label
    image of package label









  • INGREDIENTS AND APPEARANCE
    LIP BALM 
    octinoxate oxybenzone dimethicone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-202-055 in 1 BOX
    1NDC:49852-202-353.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/28/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture
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