Label: BLISTEX  COMPLETE MOISTURE- octinoxate, oxybenzone and dimethicone stick 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Dimethicone 2.0%(w/w) Lip protectant
    Octinoxate 7.5%(w/w) Sunscreen
    Oxybenzone 2.5%(w/w) Sunscreen
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  • Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • helps prevent sunburn
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  • 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.

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  • 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
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  • 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

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  • Other information

    • protect the product in this container from excessive heat and direct sun
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  • 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
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  • INGREDIENTS AND APPEARANCE
    BLISTEX   COMPLETE MOISTURE
    octinoxate, oxybenzone, and dimethicone stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10157-9877
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (Octinoxate) Octinoxate 7.5 g  in 100 g
    Oxybenzone (Oxybenzone) Oxybenzone 2.5 g  in 100 g
    Dimethicone (Dimethicone) Dimethicone 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    DIETHYLHEXYL ADIPATE  
    PROPYLPARABEN  
    BUTYLPARABEN  
    ETHYLPARABEN  
    METHYLPARABEN  
    water  
    saccharin sodium  
    squalane  
    panthenol  
    microcrystalline wax  
    glycerin  
    ETHYLHEXYL STEARATE  
    ETHYLHEXYL PALMITATE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    petrolatum  
    7-BEHENOYLSTEARIC ACID  
    SODIUM BORATE  
    CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE  
    ceresin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10157-9877-1 1 in 1 CARTON
    1 4.25 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 03/05/2003
    Labeler - Blistex Inc. (005126354)
    Establishment
    Name Address ID/FEI Business Operations
    Blistex Inc. 005126354 MANUFACTURE(10157-9877)
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