Label: SILK AND SHINE- 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 October 17, 2012

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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

    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

    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

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack

    NDC 10157-9882-1
    Blistex®
    LIP PROTECTANT/SUNSCREEN

    SILK &
    SHINE®

    Now!
    More Silk
    More Shine

    Satiny Smooth Lips
    Plus A Light Glossy Shine
    SPF 15

    Infused With Real Silk Extracts

    NET WT. .13 oz (3.69g)

    PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    SILK AND SHINE 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9882
    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)  
    isopropyl behenate (UNII: 1BWO0L9BHI)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
    Silk, Acid Hydrolyzed (1000 MW) (UNII: 8549W658QV)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9882-11 in 1 BLISTER PACK
    13.69 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/01/2012
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9882)
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