Drug Facts

Active ingredients	Purpose
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 - Kit Blister Pack

NDC 10157-8014-1

SPF 15

Blistex®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

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

FREE
Orange
Cream
LIMITED EDITION
STICK

4 Sticks Net Wt. 0.10 oz. (2.83 g) Ea.

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

FRUIT SMOOTHIES
dimethicone, octinoxate, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-8014

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10157-8014-1	1 in 1 BLISTER PACK

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CYLINDER	2.83 g
Part 2	1 CYLINDER	2.83 g
Part 3	1 CYLINDER	2.83 g
Part 4	1 CYLINDER	2.83 g

Part 1 of 4

FRUIT SMOOTHIES ORANGE CREAM
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2.83 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Part 2 of 4

FRUIT SMOOTHIES TRIPLE TROPICAL
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2.83 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Part 3 of 4

FRUIT SMOOTHIES MELON MEDLEY
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2.83 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Part 4 of 4

FRUIT SMOOTHIES BERRY EXPLOSION
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2.83 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Labeler - Blistex Inc. (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc.		005126354	MANUFACTURE(10157-8014)

Fruit Smoothies®