FRUIT SMOOTHIES- dimethicone, octinoxate, and oxybenzone   
Blistex Inc.

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.

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Drug Facts

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

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

alumina1, bis-PEG-12 dimethicone beeswax, blue 1 lake1, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate1, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid1, propylparaben, purified water, red 30 lake1, silica1, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide1, tridecyl neopentanoate, triisononanoin, yellow 101

1
May contain one or more of these ingredients.

PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

NDC 10157-9857-1

SPF 15

Blistex®
LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

4 Creamy Blends with Natural
Fruit Extracts, Flavors & Vitamins

FREE
Orange
Cream
LIMITED EDITION
STICK

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

Principal Display Panel - 4 Stick Blister Pack
FRUIT SMOOTHIES 
dimethicone, octinoxate, and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9857
Packaging
#Item CodePackage Description
1NDC:10157-9857-11 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 STRAWBERRY BANANA 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone2 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 
C20-40 pareth-3 
glycerin 
glyceryl monostearate 
hydrogenated castor oil 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
panthenol 
TRIISONONANOIN 
silicon dioxide 
saccharin sodium 
squalane 
sucralose 
tetrahexyldecyl ascorbate 
titanium dioxide 
tridecyl neopentanoate 
water 
ceresin 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
METHYLPARABEN 
Product Characteristics
ColorREDScore    
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 FINALpart34707/31/201308/07/2013
Part 2 of 4
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) Dimethicone2 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 
C20-40 pareth-3 
glycerin 
glyceryl monostearate 
hydrogenated castor oil 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
panthenol 
TRIISONONANOIN 
silicon dioxide 
saccharin sodium 
squalane 
sucralose 
tetrahexyldecyl ascorbate 
titanium dioxide 
tridecyl neopentanoate 
water 
D&C red no. 30 
D&C yellow no. 10 
ceresin 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
METHYLPARABEN 
Product Characteristics
ColorYELLOWScore    
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 FINALpart34707/31/201308/07/2013
Part 3 of 4
FRUIT SMOOTHIES ORANGE CREAM 
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone2 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C20-40 pareth-3 
glycerin 
glyceryl monostearate 
hydrogenated castor oil 
microcrystalline wax 
myristyl myristate 
panthenol 
TRIISONONANOIN 
saccharin sodium 
squalane 
sucralose 
tetrahexyldecyl ascorbate 
tridecyl neopentanoate 
water 
ceresin 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
METHYLPARABEN 
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 FINALpart34707/31/201308/07/2013
Part 4 of 4
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) Dimethicone2 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 
C20-40 pareth-3 
glycerin 
glyceryl monostearate 
hydrogenated castor oil 
isopropyl myristate 
microcrystalline wax 
myristyl myristate 
panthenol 
TRIISONONANOIN 
silicon dioxide 
saccharin sodium 
squalane 
sucralose 
tetrahexyldecyl ascorbate 
titanium dioxide 
tridecyl neopentanoate 
water 
FD&C blue no. 1 
D&C red no. 30 
ceresin 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
METHYLPARABEN 
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 FINALpart34707/31/201308/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/31/201308/07/2013
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9857)

Revised: 08/2013
Document Id: 3f2d5dbe-c7ee-4499-af0d-6ab74a0100e1
Set id: 0f72c669-adef-4825-b39c-96e400c021f1
Version: 2
Effective Time: 20130808
 
Blistex Inc.