Label: BLISTEX COMPLETE CARE (BLISTEX LIP MEDEX, BLISTEX MEDICATED LIP, BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM, AND BLISTEX COMPLETE MOISTURE) (petrolatum, menthol, unspecified form, camphor- synthetic, phenol, dimethicone, avobenzone, homosalate, octinoxate, and octisalate kit

  • Category: HUMAN OTC DRUG LABEL

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 December 7, 2018

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  • SPL UNCLASSIFIED SECTION

    LIP MEDEX®

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 1.0% (w/w)External analgesic
    Menthol 1.0% (w/w)External analgesic
    Petrolatum 59.14% (w/w)Lip protectant
    Phenol 0.54% (w/w)External analgesic
  • Uses

    • for the temporary relief of pain and itching associated with minor lip irritation
    • temporarily protects and helps relieve chapped or cracked lips
    • helps protect lips from the drying effects of wind and cold weather
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body or bandage

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: Consult a doctor
  • Inactive ingredients

    beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

  • SPL UNCLASSIFIED SECTION

    MEDICATED
    LIP OINTMENT

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 0.5% (w/w)External analgesic
    Dimethicone 1.1% (w/w)Lip protectant
    Menthol 0.625% (w/w)External analgesic
    Phenol 0.5% (w/w)External analgesic
  • Uses

    • for the temporary relief of pain and itching associated with minor lip irritation or cold sores
    • temporarily protects and helps relieve chapped or cracked lips
  • Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body or bandage

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: Consult a doctor
  • Inactive ingredients

    allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

  • SPL UNCLASSIFIED SECTION

    FIVE STAR
    LIP PROTECTION®

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0% (w/w)Sunscreen
    Dimethicone 2.0% (w/w)Lip protectant
    Homosalate 10.0% (w/w)Sunscreen
    Octinoxate 7.5% (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, calendula officinalis flower extract, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, microcrystalline wax, myristyl myristate, octyldodecanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

  • SPL UNCLASSIFIED SECTION

    COMPLETE MOISTURE®

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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

    behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum, phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane

  • PRINCIPAL DISPLAY PANEL - Blister Pack Kit

    Blistex®

    COMPLETE MOISTURE & FIVE STAR: LIP PROTECTANT/SUNSCREEN
    LIP OINTMENT & LIP MEDEX: LIP PROTECTANT/EXTERNAL ANALGESIC

    PROTECT • MOISTURIZE • RELIEVE

    BUY 3 GET 1 BONUS

    1 Jar Net Wt. 0.25 oz (7.08 g)
    1 Tube Net Wt. 0.21 oz. (6 g)

    2 Sticks Net Wt. 0.15 oz.
    (4.25 g) ea.

    PRINCIPAL DISPLAY PANEL - Blister Pack Kit
  • INGREDIENTS AND APPEARANCE
    BLISTEX COMPLETE CARE (BLISTEX LIP MEDEX, BLISTEX MEDICATED LIP, BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM, AND BLISTEX COMPLETE MOISTURE) 
    petrolatum, menthol, unspecified form, camphor (synthetic), phenol, dimethicone, avobenzone, homosalate, octinoxate, and octisalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9904
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9904-11 in 1 BLISTER PACK11/20/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 JAR 7.08 g
    Part 21 TUBE 6 g
    Part 31 CYLINDER 4.25 g
    Part 41 CYLINDER 4.25 g
    Part 1 of 4
    BLISTEX LIP MEDEX 
    petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59.14 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 g  in 100 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
    SACCHARIN (UNII: FST467XS7D)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.08 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/20/2018
    Part 2 of 4
    BLISTEX MEDICATED LIP 
    dimethicone, camphor (synthetic), menthol, unspecified form, and phenol ointment
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.1 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.625 g  in 100 g
    Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    16 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/20/2018
    Part 3 of 4
    BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM 
    dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Myristyl Myristate (UNII: 4042ZC00DY)  
    Stearyl Behenate (UNII: A68S9UI39D)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBIC ACID (UNII: X045WJ989B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/20/2018
    Part 4 of 4
    BLISTEX COMPLETE MOISTURE 
    dimethicone, octinoxate, and octisalate stick
    Product Information
    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
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SQUALANE (UNII: GW89575KF9)  
    CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/20/2018
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9904)
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