Label: BLISTEX LIP VIBRANCE- octinoxate, oxybenzone, and dimethicone stick

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

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 March 26, 2013

If you are a consumer or patient 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

    arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, butylene glycol, butyrospermum parkii (shea butter), D&C red no. 6, D&C red no. 7, ethylhexyl palmitate, flavors, hydrogenated polyisobutene, iron oxides, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, polyethylene, PPG-5-ceteth-20, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil

  • Other information

    • protect the product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 3.69g Container Blister Pack

    NDC 10157-9831-1
    Blistex®
    LIP PROTECTANT/SUNSCREEN

    LIP
    VIBRANCE    ™

    New!

    A Touch Of Color & Shimmer
    That Really Lasts

    Rich Moisturization & Protection

    Total Care For Your Lips' Complexion

    SPF 15

    Built-in Mirror

    NET WT. .13 oz (3.69g)

    PRINCIPAL DISPLAY PANEL - 3.69g Container Blister Pack
  • INGREDIENTS AND APPEARANCE
    BLISTEX   LIP VIBRANCE
    octinoxate, oxybenzone, and dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9831
    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
    arachidyl alcohol (UNII: 1QR1QRA9BU)  
    arachidyl glucoside (UNII: 6JVW35JOOJ)  
    docosanol (UNII: 9G1OE216XY)  
    butylene glycol (UNII: 3XUS85K0RA)  
    shea butter (UNII: K49155WL9Y)  
    D&C red no. 6 (UNII: 481744AI4O)  
    D&C red no. 7 (UNII: ECW0LZ41X8)  
    ethylhexyl palmitate (UNII: 2865993309)  
    mica (UNII: V8A1AW0880)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    mineral oil (UNII: T5L8T28FGP)  
    panthenyl ethyl ether (UNII: F4WMF8NX3B)  
    paraffin (UNII: I9O0E3H2ZE)  
    pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
    petrolatum (UNII: 4T6H12BN9U)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    PPG-5-ceteth-20 (UNII: 4AAN25P8P4)  
    castor oil (UNII: D5340Y2I9G)  
    saccharin (UNII: FST467XS7D)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    grape seed oil (UNII: 930MLC8XGG)  
    ferric oxide red (UNII: 1K09F3G675)  
    ceresin (UNII: Q1LS2UJO3A)  
    sandalwood (UNII: 3641YW25N2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9831-11 in 1 BLISTER PACK
    13.69 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34705/31/2013
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-9831)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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