Label: BLISTEX MEDICATED LIP BALM- dimethicone, octinoxate, and octisalate stick

  • NDC Code(s): 10157-1119-1, 10157-1119-2, 10157-1119-3, 10157-1119-4, view more
    10157-1119-5
  • Packager: Blistex Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients   Purpose
    Dimethicone 2.0% (w/w)Lip protectant
    Octinoxate 6.6% (w/w)Sunscreen
    Octisalate 4.4% (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

    beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

  • PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    MEDICATED
    LIP BALM

    Seals In Moisture
    To Soothe & Prevent Dry Lips

    Net Wt. 0.15 oz. (4.25 g)
    SPF 15

    Smooth
    Easy-Gliding
    Protection

    PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX MEDICATED LIP BALM 
    dimethicone, octinoxate, and octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1119
    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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1119-11 in 1 CARTON01/15/2018
    14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:10157-1119-33 in 1 CARTON01/15/2018
    24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:10157-1119-44 in 1 CARTON01/15/2018
    34.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    4NDC:10157-1119-55 in 1 CARTON12/16/2020
    44.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    5NDC:10157-1119-24.25 g in 1 CYLINDER; Type 0: Not a Combination Product02/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01601/15/2018
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-1119)
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