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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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

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

Other information

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 - 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

Principal Display Panel - 3 Stick Blister Pack
FRUIT SMOOTHIES 
dimethicone, octinoxate, and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-8009
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-8009-11 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 1 of 3
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 2 of 3
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 3 of 3
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(10157-8009)

Revised: 9/2013
Document Id: b1492fa2-6f92-4bf8-8270-e5b01d5217af
Set id: 38d7b411-41e3-406f-be6a-9d65272d6a45
Version: 1
Effective Time: 20130903
 
Blistex Inc.