Label: BLISTEX SOFT AND LUSH- 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 March 30, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (w/w)Lip protectant
    Octinoxate 6.6% (w/w)Sunscreen
    Oxybenzone 3.0% (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

    alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, microcrystalline wax, paraffin, PEG-8, PEG-60 hydrogenated castor oil, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, titanium dioxide

  • PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

    NDC 10157-1100-1

    Blistex®

    LIP PROTECTANT/SUNSCREEN

    ENHANCEMENT SERIES®

    Soft &
    Lush®

    New!

    Creamy Smooth Texture
    For Supple, Kissable Lips

    Ceramide-Enhanced Formula
    Softens & Conditions

    SPF 15

    Net Wt. 0.13 oz. (3.69 g)

    PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX SOFT AND LUSH 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1100
    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) Octinoxate6.6 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SACCHARIN (UNII: FST467XS7D)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1100-11 in 1 BLISTER PACK
    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 FINALpart34707/01/2015
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-1100)
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