Label: BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM- homosalate, octisalate, avobenzone, and dimethicone stick

  • NDC Code(s): 10157-1171-1, 10157-1171-2, 10157-1171-3
  • Packager: Blistex Inc.
  • 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 August 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0% (w/w)Sunscreen
    Dimethicone 2.0% (w/w)Lip Protectant
    Homosalate 15.0 % (w/w)Sunscreen
    Octisalate 5.0 % (w/w)Sunscreen
  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

    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:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.-2 p.m.
      • wear long sleeve shirts, pants, hats, and sunglasses
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, butyloctyl salicylate, C12-15 alkyl benzoate, calendula officinalis extract, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, microcrystalline wax, myristyl myristate, octyldodecanol, oryzanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

  • PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack

    The Ultimate
    Daily Protection
    For Lips

    Blistex®

    FIVE STAR
    Lip Protection®

    PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX   FIVE STAR LIP PROTECTION BROAD SPECTRUM
    homosalate, octisalate, avobenzone, and dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-1171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CERESIN (UNII: Q1LS2UJO3A)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STEARYL BEHENATE (UNII: A68S9UI39D)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ORYZANOL (UNII: SST9XCL51M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBIC ACID (UNII: X045WJ989B)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-1171-11 in 1 BLISTER PACK08/22/2020
    14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:10157-1171-22 in 1 BLISTER PACK08/22/2020
    24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:10157-1171-33 in 1 BLISTER PACK08/22/2020
    34.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/22/2020
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-1171)
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