Label: BLISTEX NURTURE AND NOURISH- octinoxate, oxybenzone, and dimethicone 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 25, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

    beeswax, euterpe oleracea (acai) fruit extract, flavor, helianthus annuus (sunflower) seed oil, hydrogenated vegetable oil, jojoba esters, lanolin alcohol, lycium barbarum (goji) fruit extract, microcrystalline wax, octyldodecanol, olea europaea (olive) fruit oil, ozokerite, petrolatum, phenoxyethanol, polybutene, ricinus communis (castor) seed oil, saccharin, saccharomyces/copper ferment, saccharomyces/magnesium ferment, saccharomyces/potassium ferment, saccharomyces/zinc ferment, sorbic acid, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vitis vinifera (grape) seed oil

  • Other information

    • protect the product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 4.25g Stick Carton

    Exceptionally
    Healthy Lips
    Inside & Out

    Blistex®

    PRINCIPAL DISPLAY PANEL - 4.25g Stick Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   NURTURE AND NOURISH
    octinoxate, oxybenzone, and dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9826
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    yellow wax (UNII: 2ZA36H0S2V)  
    acai (UNII: 46AM2VJ0AW)  
    sunflower oil (UNII: 3W1JG795YI)  
    lanolin alcohols (UNII: 884C3FA9HE)  
    lycium barbarum fruit (UNII: 930626MWDL)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    octyldodecanol (UNII: 461N1O614Y)  
    olive oil (UNII: 6UYK2W1W1E)  
    petrolatum (UNII: 4T6H12BN9U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    castor oil (UNII: D5340Y2I9G)  
    saccharin (UNII: FST467XS7D)  
    sorbic acid (UNII: X045WJ989B)  
    squalane (UNII: GW89575KF9)  
    cocoa butter (UNII: 512OYT1CRR)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    grape seed oil (UNII: 930MLC8XGG)  
    ceresin (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9826-11 in 1 CARTON
    14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/31/2013
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9826)
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