Label: BLISTEX RASPBERRY LEMONADE BLAST- dimethicone, octinoxate, and oxybenzone 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 12, 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 1.0% (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

    alumina, beeswax, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, glyceryl stearate, hydrogenated coconut oil, isopropyl myristate, isopropyl palmitate, isopropyl stearate, jojoba esters, microcrystalline wax, myristyl myristate, phenoxyethanol, phenyl trimethicone, polyethylene, polyhydroxystearic acid, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate

  • Other information

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

    Blistex®

    SPF 15

    RaSPBeRRY
    LemonaDe BLaST    ®

    NET WT. .15 oz (4.25g)

    Principal Display Panel - 4.25 g Cylinder Label
  • INGREDIENTS AND APPEARANCE
    BLISTEX   RASPBERRY LEMONADE BLAST
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    aluminum oxide (UNII: LMI26O6933)  
    yellow wax (UNII: 2ZA36H0S2V)  
    diethylhexyl adipate (UNII: MBY1SL921L)  
    ethylhexyl palmitate (UNII: 2865993309)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    hydrogenated coconut oil (UNII: JY81OXM1OM)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    saccharin (UNII: FST467XS7D)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeBULLETSize
    FlavorRASPBERRY (lemonade) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-9800-14.25 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/01/2010
    Labeler - Blistex Inc (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc005126354MANUFACTURE(10157-9800)
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!