Label: BLISTEX ENHANCEMENT SERIES (DEEP RENEWAL AND SILK AND SHINE)- avobenzone, dimethicone, octinoxate, octocrylene and oxybenzone kit

  • 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 December 5, 2014

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  • SPL UNCLASSIFIED SECTION

    DEEP RENEWAL®

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0% (w/w)Sunscreen
    Dimethicone 2.0% (w/w)Lip protectant
    Octinoxate 7.5% (w/w)Sunscreen
    Octocrylene 2.7% (w/w)Sunscreen
    Oxybenzone 2.5% (w/w)Sunscreen
  • Uses

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

    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.

    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
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.-2 p.m.
      • wear long sleeve shirts, pants, hats, and sunglasses
    • 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

    atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

  • SPL UNCLASSIFIED SECTION

    SILK & SHINE®

    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

    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

    arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, flavors, hydrogenated polyisobutene, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, PPG-5-Ceteth-20, saccharin, titanium dioxide, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL - Kit Blister Pack

    NDC 10157-9865-1

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    ENHANCEMENT SERIES®

    VALUE PACK
    Anti-aging rejuvenation
    Satiny smooth & light shine

    BROAD SPECTRUM SPF 15

    2 Sticks Net Wt. 0.13 oz. (3.69 g) Ea.

    SPF 15

    Principal Display Panel - Kit Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX ENHANCEMENT SERIES (DEEP RENEWAL AND SILK AND SHINE) 
    avobenzone, dimethicone, octinoxate, octocrylene and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9865
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9865-11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 3.69 g
    Part 21 CYLINDER 3.69 g
    Part 1 of 2
    BLISTEX DEEP RENEWAL 
    dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene 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
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    yellow wax (UNII: 2ZA36H0S2V)  
    butylene glycol (UNII: 3XUS85K0RA)  
    dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)  
    ethylhexyl palmitate (UNII: 2865993309)  
    lanolin alcohols (UNII: 884C3FA9HE)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    octyldodecanol (UNII: 461N1O614Y)  
    pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)  
    petrolatum (UNII: 4T6H12BN9U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    high density polyethylene (UNII: UG00KM4WR7)  
    polytetrafluoroethylene (UNII: E1NC1JVS3O)  
    castor oil (UNII: D5340Y2I9G)  
    saccharin (UNII: FST467XS7D)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    sorbic acid (UNII: X045WJ989B)  
    squalane (UNII: GW89575KF9)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    Polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    CHONDROITIN SULFATE SODIUM (SHARK) (UNII: Q75WVO004L)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/2012
    Part 2 of 2
    BLISTEX SILK AND SHINE 
    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
    arachidyl alcohol (UNII: 1QR1QRA9BU)  
    arachidyl glucoside (UNII: 6JVW35JOOJ)  
    docosanol (UNII: 9G1OE216XY)  
    mica (UNII: V8A1AW0880)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    mineral oil (UNII: T5L8T28FGP)  
    panthenyl ethyl ether (UNII: F4WMF8NX3B)  
    paraffin (UNII: I9O0E3H2ZE)  
    pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
    petrolatum (UNII: 4T6H12BN9U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
    saccharin (UNII: FST467XS7D)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    sandalwood (UNII: 3641YW25N2)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/01/2015
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9865)
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