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 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

alumina, bis-PEG-12 dimethicone beeswax, butylparaben, C20-40 pareth-3, ethylparaben, flavors, fruit extracts, glycerin, glyceryl stearate, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, lecithin, methylparaben, microcrystalline wax, myristyl myristate, ozokerite, panthenol, pantothenic acid polypeptide, polybutene, polyhydroxystearic acid, propylparaben, purified water, silica, sodium saccharin, squalane, sucralose, tetrahexyldecyl ascorbate, titanium dioxide, tridecyl neopentanoate, triisononanoin May contain: blue 1 lake, red 30 lake, yellow 10.

Other information

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

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

NDC: 10157-9883-3

SPF 15

Blistex®

LIP PROTECTANT/SUNSCREEN

Fruit
Smoothies®

3 Creamy Blends with Natural
Fruit Extracts, Flavors & Vitamins

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

INGREDIENTS AND APPEARANCE

FRUIT SMOOTHIES 
dimethicone, octinoxate, and oxybenzone kit

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9883-3	1 in 1 BLISTER PACK

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

Part 1 of 3

FRUIT SMOOTHIES MELON MEDLEY 
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.83 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/14/2013

Part 2 of 3

FRUIT SMOOTHIES TRIPLE TROPICAL 
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.83 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/14/2013

Part 3 of 3

FRUIT SMOOTHIES BERRY EXPLOSION 
dimethicone, octinoxate, and oxybenzone stick

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2.83 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/14/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/14/2013

Labeler - Blistex Inc. (005126354)

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