FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]

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  • FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]

FRUIT SMOOTHIES (DIMETHICONE, OCTINOXATE, AND OXYBENZONE) KIT [BLISTEX INC.]
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NDC 10157-9883-6
Set ID 1216c025-8e8d-4919-857d-da22b309681a
Category HUMAN OTC DRUG LABEL
Packager Blistex Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (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
  • Inactive ingredients

    alumina1, bis-PEG-12 dimethicone beeswax, blue 1 lake1, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate1, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid1, propylparaben, purified water, red 30 lake1, silica1, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide1, tridecyl neopentanoate, triisononanoin, yellow 101

    1
    May contain one or more of these ingredients.
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

    NDC 10157-9883-6

    SPF 15

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    Fruit
    Smoothies    ®

    4 Creamy Blends with Natural
    Fruit Extracts, Flavors & Vitamins

    FREE
    Orange
    Cream
    LIMITED EDITION
    STICK

    4 STICKS NET WT. .10 oz (2.83g) EACH

    PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack
  • INGREDIENTS AND APPEARANCE
    FRUIT SMOOTHIES 
    dimethicone, octinoxate, and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9883
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9883-61 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 2.83 g
    Part 21 CYLINDER 2.83 g
    Part 31 CYLINDER 2.83 g
    Part 41 CYLINDER 2.83 g
    Part 1 of 4
    FRUIT SMOOTHIES MELON MEDLEY 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 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
    aluminum oxide (UNII: LMI26O6933)  
    C20-40 pareth-3 (UNII: 68103A23TQ)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated castor oil (UNII: ZF94AP8MEY)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    panthenol (UNII: WV9CM0O67Z)  
    triisononanoin (UNII: XF4K22WN6T)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    squalane (UNII: GW89575KF9)  
    sucralose (UNII: 96K6UQ3ZD4)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    tridecyl neopentanoate (UNII: 3Z8H1DA7J5)  
    water (UNII: 059QF0KO0R)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    ceresin (UNII: Q1LS2UJO3A)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    methylparaben (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2012
    Part 2 of 4
    FRUIT SMOOTHIES TRIPLE TROPICAL 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 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
    aluminum oxide (UNII: LMI26O6933)  
    C20-40 pareth-3 (UNII: 68103A23TQ)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated castor oil (UNII: ZF94AP8MEY)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    panthenol (UNII: WV9CM0O67Z)  
    triisononanoin (UNII: XF4K22WN6T)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    squalane (UNII: GW89575KF9)  
    sucralose (UNII: 96K6UQ3ZD4)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    tridecyl neopentanoate (UNII: 3Z8H1DA7J5)  
    water (UNII: 059QF0KO0R)  
    D&C red no. 30 (UNII: 2S42T2808B)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    ceresin (UNII: Q1LS2UJO3A)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    methylparaben (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2012
    Part 3 of 4
    FRUIT SMOOTHIES BERRY EXPLOSION 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 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
    aluminum oxide (UNII: LMI26O6933)  
    C20-40 pareth-3 (UNII: 68103A23TQ)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated castor oil (UNII: ZF94AP8MEY)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    panthenol (UNII: WV9CM0O67Z)  
    triisononanoin (UNII: XF4K22WN6T)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    squalane (UNII: GW89575KF9)  
    sucralose (UNII: 96K6UQ3ZD4)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    tridecyl neopentanoate (UNII: 3Z8H1DA7J5)  
    water (UNII: 059QF0KO0R)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    D&C red no. 30 (UNII: 2S42T2808B)  
    ceresin (UNII: Q1LS2UJO3A)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    methylparaben (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2012
    Part 4 of 4
    FRUIT SMOOTHIES ORANGE CREAM 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 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
    C20-40 pareth-3 (UNII: 68103A23TQ)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated castor oil (UNII: ZF94AP8MEY)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    panthenol (UNII: WV9CM0O67Z)  
    triisononanoin (UNII: XF4K22WN6T)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    squalane (UNII: GW89575KF9)  
    sucralose (UNII: 96K6UQ3ZD4)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    tridecyl neopentanoate (UNII: 3Z8H1DA7J5)  
    water (UNII: 059QF0KO0R)  
    ceresin (UNII: Q1LS2UJO3A)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    methylparaben (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2012
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9883)
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