Label: DEEP RENEWAL- avobenzone, octinoxate, octocrylene, 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 10/12

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Avobenzone 3.0% (w/w) Sunscreen
    Dimethicone 2.0% (w/w) Lip protectant
    Octinoxate 7.5% (w/w) Sunscreen
    Octocrylene 2.7% (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

    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
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.-2 p.m.
      • wear long sleeve shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor.
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  • Inactive ingredients

    atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

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  • STORAGE AND HANDLING

    • protect the product in this container from excessive heat and direct sun
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  • PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack

    NDC 10157-9835-1

    Blistex®

    LIP PROTECTANT/SUNSCREEN

    DEEP
    RENEWAL®

    ANTI-AGING TREATMENT

    • Visibly Reduces Deep & Fine Lines
    • Improves Lip Health & Vitality
    • Moisturizes, Protects & Renews

    coenzyme
    Q•10

    with
    Hyaluronic
    Spheres

    BROAD
    SPECTRUM
    SPF 15

    NET WT. .13 oz (3.69g)

    PRINCIPAL DISPLAY PANEL - 3.69g Cylinder Blister Pack
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  • INGREDIENTS AND APPEARANCE
    DEEP RENEWAL 
    avobenzone, octinoxate, octocrylene, oxybenzone, and dimethicone stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10157-9835
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Avobenzone (Avobenzone) Avobenzone 3 g  in 100 g
    Octinoxate (Octinoxate) Octinoxate 7.5 g  in 100 g
    Octocrylene (Octocrylene) Octocrylene 2.7 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
    yellow wax  
    butylene glycol  
    dipalmitoyl hydroxyproline  
    ethylhexyl palmitate  
    lanolin alcohols  
    microcrystalline wax  
    octyldodecanol  
    pentaerythrityl tetraisostearate  
    petrolatum  
    phenoxyethanol  
    high density polyethylene  
    polytetrafluoroethylene  
    castor oil  
    saccharin  
    silica dimethyl silylate  
    hyaluronate sodium  
    sorbic acid  
    squalane  
    tetrahexyldecyl ascorbate  
    Polybutene (1400 MW)  
    FISH SKIN COLLAGEN, SOLUBLE  
    CHONDROITIN SULFATE SODIUM (SHARK)  
    UBIDECARENONE  
    SIMMONDSIA CHINENSIS SEED WAX  
    .alpha.-tocopherol acetate  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor MINT (Citrus Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10157-9835-1 1 in 1 BLISTER PACK
    1 3.69 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 11/01/2012
    Labeler - Blistex Inc (005126354)
    Establishment
    Name Address ID/FEI Business Operations
    Blistex Inc 005126354 MANUFACTURE(10157-9835)
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