Drug Facts

Active ingredients	Purpose
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

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.

Other information

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

PRINCIPAL DISPLAY PANEL - 4 Stick Blister Pack

NDC 10157-9883-6

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-9883

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10157-9883-6	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 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	2 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)
C20-40 pareth-3 (UNII: 68103A23TQ)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated castor oil (UNII: ZF94AP8MEY)
isopropyl myristate (UNII: 0RE8K4LNJS)
microcrystalline wax (UNII: XOF597Q3KY)
myristyl myristate (UNII: 4042ZC00DY)
panthenol (UNII: WV9CM0O67Z)
triisononanoin (UNII: XF4K22WN6T)
silicon dioxide (UNII: ETJ7Z6XBU4)
saccharin sodium (UNII: SB8ZUX40TY)
squalane (UNII: GW89575KF9)
sucralose (UNII: 96K6UQ3ZD4)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
titanium dioxide (UNII: 15FIX9V2JP)
tridecyl neopentanoate (UNII: 3Z8H1DA7J5)
water (UNII: 059QF0KO0R)
FD&C blue no. 1 (UNII: H3R47K3TBD)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
ceresin (UNII: Q1LS2UJO3A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
methylparaben (UNII: A2I8C7HI9T)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/01/2012

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	2 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)
C20-40 pareth-3 (UNII: 68103A23TQ)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated castor oil (UNII: ZF94AP8MEY)
isopropyl myristate (UNII: 0RE8K4LNJS)
microcrystalline wax (UNII: XOF597Q3KY)
myristyl myristate (UNII: 4042ZC00DY)
panthenol (UNII: WV9CM0O67Z)
triisononanoin (UNII: XF4K22WN6T)
silicon dioxide (UNII: ETJ7Z6XBU4)
saccharin sodium (UNII: SB8ZUX40TY)
squalane (UNII: GW89575KF9)
sucralose (UNII: 96K6UQ3ZD4)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
titanium dioxide (UNII: 15FIX9V2JP)
tridecyl neopentanoate (UNII: 3Z8H1DA7J5)
water (UNII: 059QF0KO0R)
D&C red no. 30 (UNII: 2S42T2808B)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
ceresin (UNII: Q1LS2UJO3A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
methylparaben (UNII: A2I8C7HI9T)

Product Characteristics
Color	YELLOW	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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/01/2012

Part 3 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	2 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)
C20-40 pareth-3 (UNII: 68103A23TQ)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated castor oil (UNII: ZF94AP8MEY)
isopropyl myristate (UNII: 0RE8K4LNJS)
microcrystalline wax (UNII: XOF597Q3KY)
myristyl myristate (UNII: 4042ZC00DY)
panthenol (UNII: WV9CM0O67Z)
triisononanoin (UNII: XF4K22WN6T)
silicon dioxide (UNII: ETJ7Z6XBU4)
saccharin sodium (UNII: SB8ZUX40TY)
squalane (UNII: GW89575KF9)
sucralose (UNII: 96K6UQ3ZD4)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
titanium dioxide (UNII: 15FIX9V2JP)
tridecyl neopentanoate (UNII: 3Z8H1DA7J5)
water (UNII: 059QF0KO0R)
FD&C blue no. 1 (UNII: H3R47K3TBD)
D&C red no. 30 (UNII: 2S42T2808B)
ceresin (UNII: Q1LS2UJO3A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
methylparaben (UNII: A2I8C7HI9T)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/01/2012

Part 4 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	2 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
C20-40 pareth-3 (UNII: 68103A23TQ)
glycerin (UNII: PDC6A3C0OX)
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated castor oil (UNII: ZF94AP8MEY)
microcrystalline wax (UNII: XOF597Q3KY)
myristyl myristate (UNII: 4042ZC00DY)
panthenol (UNII: WV9CM0O67Z)
triisononanoin (UNII: XF4K22WN6T)
saccharin sodium (UNII: SB8ZUX40TY)
squalane (UNII: GW89575KF9)
sucralose (UNII: 96K6UQ3ZD4)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
tridecyl neopentanoate (UNII: 3Z8H1DA7J5)
water (UNII: 059QF0KO0R)
ceresin (UNII: Q1LS2UJO3A)
propylparaben (UNII: Z8IX2SC1OH)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
methylparaben (UNII: A2I8C7HI9T)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2012

Labeler - Blistex Inc. (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc.		005126354	MANUFACTURE(10157-9883)

Blistex (Fruit Smoothies)