Label: BLISTEX EUROPEAN FORMULA- lanolin, octinoxate, and oxybenzone paste

  • 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 16, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lanolin 13 .0%(w/w)Skin Protectant
    Octinoxate 7.5%(w/w)Sunscreen
    Oxybenzone 2.5%(w/w)Sunscreen
  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps protect lips from the drying effects of wind and cold weather
    • helps prevent sunburn
  • Warnings

    • Stop use if skin rash occurs
  • Directions

    • apply liberally before sun exposure and as needed
  • Inactive ingredients

    aloe barbadensis leaf extract, camphor, cetyl alcohol, cocoyl hydrolyzed soy protein, euphorbia cerifera (candelilla) wax, fragrance, isostearoyl hydrolyzed collagen, menthol, microcrystalline wax, olea europaea (olive) fruit oil, petrolatum, saccharin, theobroma cacao (cocoa) seed butter, thymol, tocopheryl acetate, vanillin, vitis vinifera (grape) seed oil

  • SPL UNCLASSIFIED SECTION

    #34280
    ©2011 Blistex Inc.,
    P.O. Box 5392,
    Oak Brook, IL 60522-5392

  • PRINCIPAL DISPLAY PANEL - 7 g Container Label

    NDC 10157-9539-1

    Blistex®

    LIP PROTECTANT/
    SUNSCREEN

    SPF
    15

    EUROPEAN FORMULA
    LIP CONDITIONER    ™

    Moisturizes & Protects For Healthy, Beautiful Lips

    Enriched with Olive & Grapeseed Oils,
    Vitamin E, Cocoa Butter, Lanolin and Collagen

    NET WT. .25 oz (7g)

    Principal Display Panel - 7 g Container Label
  • INGREDIENTS AND APPEARANCE
    BLISTEX   EUROPEAN FORMULA
    lanolin, octinoxate, and oxybenzone paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9539
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lanolin (UNII: 7EV65EAW6H) (Lanolin - UNII:7EV65EAW6H) Lanolin13 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
    aloe vera leaf (UNII: ZY81Z83H0X)  
    camphor (synthetic) (UNII: 5TJD82A1ET)  
    cetyl alcohol (UNII: 936JST6JCN)  
    candelilla wax (UNII: WL0328HX19)  
    menthol (UNII: L7T10EIP3A)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    olive oil (UNII: 6UYK2W1W1E)  
    petrolatum (UNII: 4T6H12BN9U)  
    saccharin (UNII: FST467XS7D)  
    cocoa butter (UNII: 512OYT1CRR)  
    thymol (UNII: 3J50XA376E)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    vanillin (UNII: CHI530446X)  
    grape seed oil (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9539-11 in 1 BLISTER PACK
    17 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2011
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9539)
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