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Fruit Smoothies by Blistex Inc.

Medically reviewed on September 4, 2017

Dosage form: kit
Ingredients: Dimethicone 1g in 100g, Octinoxate 7.5g in 100g, Oxybenzone 2.5g in 100g
Labeler: Blistex Inc.
NDC Code: 10157-8009

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.

Fruit Smoothies®

Drug Facts

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 lake, 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


May contain one or more of these ingredients.

PRINCIPAL DISPLAY PANEL - 3 Stick Blister Pack

SPF 15

NDC 10157-8009-1

Blistex®
LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

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

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

FRUIT SMOOTHIES 
dimethicone, octinoxate, and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8009
Packaging
#Item CodePackage Description
1NDC:10157-8009-11 KIT 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 1 of 3
FRUIT SMOOTHIES TRIPLE TROPICAL 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone1 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
aluminum oxide 
yellow wax 
diethylhexyl adipate 
glyceryl monostearate 
ethylhexyl palmitate 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
phenoxyethanol 
ethylhexyl stearate 
silicon dioxide 
hydrogenated coconut oil 
isopropyl palmitate 
isopropyl stearate 
tetrahexyldecyl ascorbate 
titanium dioxide 
phenyl trimethicone 
high density polyethylene 
D&C red no. 30 
D&C yellow no. 10 
saccharin 
.alpha.-tocopherol acetate 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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 3
FRUIT SMOOTHIES MELON MEDLEY 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone1 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
aluminum oxide 
yellow wax 
diethylhexyl adipate 
glyceryl monostearate 
ethylhexyl palmitate 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
phenoxyethanol 
ethylhexyl stearate 
silicon dioxide 
hydrogenated coconut oil 
isopropyl palmitate 
isopropyl stearate 
tetrahexyldecyl ascorbate 
titanium dioxide 
phenyl trimethicone 
high density polyethylene 
FD&C blue no. 1 
D&C yellow no. 10 
saccharin 
.alpha.-tocopherol acetate 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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 3
FRUIT SMOOTHIES BERRY EXPLOSION 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone1 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
aluminum oxide 
yellow wax 
diethylhexyl adipate 
glyceryl monostearate 
ethylhexyl palmitate 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
phenoxyethanol 
ethylhexyl stearate 
silicon dioxide 
hydrogenated coconut oil 
isopropyl palmitate 
isopropyl stearate 
tetrahexyldecyl ascorbate 
titanium dioxide 
phenyl trimethicone 
high density polyethylene 
FD&C blue no. 1 
D&C red no. 30 
saccharin 
.alpha.-tocopherol acetate 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Blistex Inc.005126354MANUFACTURE(10157-8009)

 
Blistex Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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