Label: FRUIT SMOOTHIES- dimethicone, octinoxate, and oxybenzone kit

  • 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 September 3, 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

    PACKAGE WARNING

    CHOKING HAZARD. Has removable cap. Not for children under 3 years.

    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
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    alumina, beeswax, blue 1 lake1, 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, red 30 lake1, saccharin, silica, tetrahexyldecyl ascorbate, titanium dioxide, tocopheryl acetate, yellow 101

    1
    May contain one or more of these ingredients.
  • PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

    NDC 10157-8013-1

    SPF 15

    Blistex®
    LIP PROTECTANT/SUNSCREEN

    Fruit
    Smoothies    ®

    4 Creamy Blends With Delicious
    Fruit Flavors And Vitamins C&E

    FREE

    Peaches
    & Cream

    LIMITED EDITION
    STICK

    4 STICKS NET WT. .10 oz (2.83g) EACH

    Principal Display Panel - 4 Stick Blister Pack
  • INGREDIENTS AND APPEARANCE
    FRUIT SMOOTHIES 
    dimethicone, octinoxate, and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8013
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10157-8013-11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 2.83 g
    Part 21 CYLINDER 2.83 g
    Part 31 CYLINDER 2.83 g
    Part 41 CYLINDER 2.83 g
    Part 1 of 4
    FRUIT SMOOTHIES PEACHES AND CREAM 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    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)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    ethylhexyl palmitate (UNII: 2865993309)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    hydrogenated coconut oil (UNII: JY81OXM1OM)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    saccharin (UNII: FST467XS7D)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/01/2013
    Part 2 of 4
    FRUIT SMOOTHIES TRIPLE TROPICAL 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    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)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    ethylhexyl palmitate (UNII: 2865993309)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    hydrogenated coconut oil (UNII: JY81OXM1OM)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    D&C red no. 30 (UNII: 2S42T2808B)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    saccharin (UNII: FST467XS7D)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/01/2013
    Part 3 of 4
    FRUIT SMOOTHIES MELON MEDLEY 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    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)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    ethylhexyl palmitate (UNII: 2865993309)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    hydrogenated coconut oil (UNII: JY81OXM1OM)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    saccharin (UNII: FST467XS7D)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/01/2013
    Part 4 of 4
    FRUIT SMOOTHIES BERRY EXPLOSION 
    dimethicone, octinoxate, and oxybenzone stick
    Product Information
    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)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    ethylhexyl palmitate (UNII: 2865993309)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    microcrystalline wax (UNII: XOF597Q3KY)  
    myristyl myristate (UNII: 4042ZC00DY)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl stearate (UNII: EG3PA2K3K5)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    hydrogenated coconut oil (UNII: JY81OXM1OM)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    isopropyl stearate (UNII: 43253ZW1MZ)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    high density polyethylene (UNII: UG00KM4WR7)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    D&C red no. 30 (UNII: 2S42T2808B)  
    saccharin (UNII: FST467XS7D)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12.83 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34709/01/2013
    Labeler - Blistex Inc. (005126354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blistex Inc.005126354MANUFACTURE(10157-8013)
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!