Label: BLISTEX MEDICATED MINT LIP BALM- dimethicone, oxybenzone, and padimate o stick

  • 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 April 8, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dimethicone 2.0% (w/w)Lip protectant
    Oxybenzone 2.5% (w/w)Sunscreen
    Padimate O 6.6% (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
  • Inactive ingredients

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

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 3 Cylinder Blister Pack

    Blistex® MEDICATED LIP BALM
    LIP PROTECTANT/SUNSCREEN

    SPF 15

    Blistex® MEDICATED LIP BALM
    NET WT. .15 oz (4.25g)

    SPF 15

    Blistex® MEDICATED LIP BALM

    ©2012 Blistex Inc.
    P.O. Box 5392, Oak Brook, IL
    60522 C36186
    23012TE

    DO NOT USE IF SEAL IS MISSING.

    Lift for Drug Facts

    PRINCIPAL DISPLAY PANEL - 3 Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX   MEDICATED MINT LIP BALM
    dimethicone, oxybenzone, and padimate o stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O6.6 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 (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    petrolatum (UNII: 4T6H12BN9U)  
    polybutene (1400 MW) (UNII: 1NA5AO9GH7)  
    propylparaben (UNII: Z8IX2SC1OH)  
    D&C red no. 6 (UNII: 481744AI4O)  
    aluminum oxide (UNII: LMI26O6933)  
    cocoa butter (UNII: 512OYT1CRR)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeBULLETSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9608-33 in 1 BLISTER PACK
    1NDC:10157-9608-14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/01/2010
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9608)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!