Blistex® Assorted Medicated Balm Value Pack (Blistex® Medicated Berry Lip Balm, Blistex® Medicated Lip Balm, Blistex® Medicated Mint Lip Balm)

Blistex Assorted Medicated Balm Value Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) by

Drug Labeling and Warnings

Blistex Assorted Medicated Balm Value Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLISTEX ASSORTED MEDICATED BALM VALUE PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED MINT LIP BALM)- dimethicone, padimate o, oxybenzone, dimethicone, octinoxate, and octisalate 
Blistex Inc

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.

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Blistex® Assorted Medicated Balm Value Pack (Blistex® Medicated Berry Lip Balm, Blistex® Medicated Lip Balm, Blistex® Medicated Mint Lip Balm)

Drug Facts

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, flavors, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate1, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake1, theobroma cacao (cocoa) seed butter, titanium dioxide

  • 1 may contain these ingredients

    • PRINCIPAL DISPLAY PANEL - Kit Carton

    VALUE PACK

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    Mint Berry Classic

    MEDICATED
    LIP BALM

    3 Balm
    VALUE
    PACK

    Smooth, Easy-Gliding
    Protection

    Seals In Moisture
    To Soothe & Prevent
    Dry Lips

    SPF 15

    3 Sticks Net Wt. 0.15 oz. (4.25 g) Ea.

    PRINCIPAL DISPLAY PANEL - Kit Carton
    BLISTEX ASSORTED MEDICATED BALM VALUE PACK (BLISTEX MEDICATED BERRY LIP BALM, BLISTEX MEDICATED LIP BALM, BLISTEX MEDICATED MINT LIP BALM) 
    dimethicone, padimate o, oxybenzone, dimethicone, octinoxate, and octisalate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10157-9900
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 10157-9900-11 in 1 CARTON11/20/201801/30/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 4.25 g
    Part 21 CYLINDER 4.25 g
    Part 31 CYLINDER 4.25 g
    Part 1 of 3
    BLISTEX MEDICATED BERRY LIP BALM 
    dimethicone, padimate o, and oxybenzone 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
    Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O6.6 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    yellow wax (UNII: 2ZA36H0S2V)  
    cetyl alcohol (UNII: 936JST6JCN)  
    cetyl palmitate (UNII: 5ZA2S6B08X)  
    candelilla wax (UNII: WL0328HX19)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    lanolin (UNII: 7EV65EAW6H)  
    lanolin oil (UNII: OVV5IIJ58F)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    petrolatum (UNII: 4T6H12BN9U)  
    propylparaben (UNII: Z8IX2SC1OH)  
    D&C red no. 6 (UNII: 481744AI4O)  
    aluminum oxide (UNII: LMI26O6933)  
    cocoa butter (UNII: 512OYT1CRR)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    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 FINALpart35211/20/201801/30/2020
    Part 2 of 3
    BLISTEX MEDICATED LIP BALM 
    octinoxate, octisalate, dimethicone 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 FINALpart34711/20/201801/30/2020
    Part 3 of 3
    BLISTEX MEDICATED MINT LIP BALM 
    octinoxate, octisalate, dimethicone 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)  
    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 FINALpart34711/20/201801/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/20/201801/30/2020
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9900)

    Revised: 1/2020
    Document Id: 1e95b653-5a0b-4fc9-9714-3d107be746b0
    Set id: 9e8df110-5c02-4daa-92dc-0dcfd5df0b10
    Version: 2
    Effective Time: 20200131
     
    Blistex Inc