Label: BLISTEX COMPLETE MOISTURE- octinoxate, oxybenzone, and dimethicone 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 November 12, 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
    Octinoxate 7.5%(w/w)Sunscreen
    Oxybenzone 2.5%(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

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

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton

    NDC 10157-9877-1

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    COMPLETE
    MOISTURE®

    Moisture Plus
    Ultra-Hydrating Ingredients

    Penetrates To Quench Dry Lips

    NET WT. .15 oz (4.25g)

    SPF 15

    PRINCIPAL DISPLAY PANEL - 4.25g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    BLISTEX   COMPLETE MOISTURE
    octinoxate, oxybenzone, and dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9877
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    water (UNII: 059QF0KO0R)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    squalane (UNII: GW89575KF9)  
    panthenol (UNII: WV9CM0O67Z)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    glycerin (UNII: PDC6A3C0OX)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    petrolatum (UNII: 4T6H12BN9U)  
    7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)  
    ceresin (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9877-11 in 1 CARTON
    14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/05/2003
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9877)
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!