Label: BLISTEX ORANGE MANGO BLAST- dimethicone, octinoxate, and oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 2, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 1.0% (w/w)Lip protectant
    Octinoxate 7.5% (w/w)Sunscreen
    Oxybenzone 2.5% (w/w)Sunscreen
  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    PACKAGE WARNING

    CHOKING HAZARD. Has removable cap. Not for children under 3 years.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    alumina, beeswax, citrus nobilis (mandarin orange) fruit extract, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

    NDC 10157-8008-1

    BLISTEX®
    LIP PROTECTANT/SUNSCREEN

    ORANGE
    MANGO
    BLAST    ™

    New!

    Comforts & Protects
    Moisturizes Dry Lips

    NET WT. .15 oz (4.25g)

    SPF 15

    Principal Display Panel - 4.25 g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   ORANGE MANGO BLAST
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Diethylhexyl Adipate (UNII: MBY1SL921L)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Isopropyl Stearate (UNII: 43253ZW1MZ)  
    Tangerine (UNII: KH3E3096OO)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Myristyl Myristate (UNII: 4042ZC00DY)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Saccharin (UNII: FST467XS7D)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-8008-11 in 1 CARTON
    14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/14/2014
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-8008)
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