FRUIT SMOOTHIES- dimethicone, octinoxate, and oxybenzone kit

Fruit Smoothies by

Drug Labeling and Warnings

Fruit Smoothies by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

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.

Active ingredients	Purpose
Dimethicone 1.0% (w/w)	Lip protectant
Octinoxate 7.5% (w/w)	Sunscreen
Oxybenzone 2.5% (w/w)	Sunscreen

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

NDC: 10157-8010-1

SPF 15

Blistex®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

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

FREE

Summer
Sweet Fruit

LIMITED EDITION
STICK

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

Principal Display Panel - Kit Blister Pack

INGREDIENTS AND APPEARANCE

FRUIT SMOOTHIES
dimethicone, octinoxate, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-8010

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 10157-8010-1	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 STRAWBERRY BANANA
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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/01/2013

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/01/2013

Part 3 of 4

FRUIT SMOOTHIES SUMMER SWEET FRUIT
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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/01/2013

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	09/01/2013

Labeler - Blistex Inc. (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc.		005126354	MANUFACTURE(10157-8010)

Trademark Results [Fruit Smoothies]

Mark Image Registration \| Serial	Company Trademark Application Date
FRUIT SMOOTHIES 76285683 2673116 Live/Registered	BLISTEX INC. 2000-09-11
FRUIT SMOOTHIES 73644567 not registered Dead/Abandoned	TCBY ENTERPRISES, INC. 1987-02-13