Label: BLISTEX MEDICATED LIP BALM VARIETY PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED LIP) (dimethicone, octinoxate, octisalate, camphor- synthetic, menthol, unspecified form, and phenol kit

  • 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 February 5, 2020

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  • SPL UNCLASSIFIED SECTION

    MEDICATED BERRY BALM

    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

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

  • SPL UNCLASSIFIED SECTION

    MEDICATED LIP BALM

    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

    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

  • 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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Blistex® MEDICATED VARIETY PACK

    Helps heal, soothe
    & protect

    There's No Bliss Like Blistex®

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX MEDICATED LIP BALM VARIETY PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED LIP) 
    dimethicone, octinoxate, octisalate, camphor (synthetic), menthol, unspecified form, and phenol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9910
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9910-11 in 1 CARTON02/03/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 4.25 g
    Part 21 CYLINDER 4.25 g
    Part 31 TUBE 6 g
    Part 1 of 3
    BLISTEX MEDICATED BERRY LIP BALM 
    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
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    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 FINALpart34702/03/2020
    Part 2 of 3
    BLISTEX MEDICATED LIP BALM 
    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
    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
    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 FINALpart34702/03/2020
    Part 3 of 3
    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 finalpart34802/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/03/2020
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9910)
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