BLISTEX ENHANCEMENT SERIES- dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kit

Blistex by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DEEP RENEWAL®

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0% (w/w)	Sunscreen
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 7.5% (w/w)	Sunscreen
Octocrylene 2.7% (w/w)	Sunscreen
Oxybenzone 2.5% (w/w)	Sunscreen

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps prevent sunburn

Warnings

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.

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
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

• protect the product from excessive heat and direct sun

Inactive ingredients

atelocollagen, beeswax, butylene glycol, dipalmitoyl hydroxyproline, ethylhexyl palmitate, flavor, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, petrolatum, phenoxyethanol, polybutene, polyethylene, PTFE, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium chondroitin sulfate, sodium hyaluronate, sorbic acid, squalane, tetrahexyldecyl ascorbate, tocopheryl acetate, ubiquinone

SPL UNCLASSIFIED SECTION

LIP VIBRANCE®

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

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 from excessive heat and direct sun

Inactive ingredients

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, butylene glycol, butyrospermum parkii (shea butter), D&C red no. 6, D&C red no. 7, ethylhexyl palmitate, flavors, hydrogenated polyisobutene, iron oxides, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, polyethylene, PPG-5-ceteth-20, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil

SPL UNCLASSIFIED SECTION

SILK & SHINE®

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

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 from excessive heat and direct sun

Inactive ingredients

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, flavors, hydrogenated polyisobutene, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, PPG-5-Ceteth-20, saccharin, titanium dioxide, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 3 Stick Blister Pack

NDC: 10157-9858-1
Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®
youthful beautiful kissable

BUY 2 GET 1 FREE

BROAD SPECTRUM
SPF15

SPF15

SPF15

3 Sticks Net Wt. 0.13 oz. (3.69 g) Each

INGREDIENTS AND APPEARANCE

BLISTEX  ENHANCEMENT SERIES
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9858

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9858-1	1 in 1 BLISTER PACK

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CYLINDER	3.69 g
Part 2	1 CYLINDER	3.69 g
Part 3	1 CYLINDER	3.69 g

Part 1 of 3

BLISTEX   LIP VIBRANCE
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
arachidyl alcohol (UNII: 1QR1QRA9BU)
ceresin (UNII: Q1LS2UJO3A)
paraffin (UNII: I9O0E3H2ZE)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
mineral oil (UNII: T5L8T28FGP)
arachidyl glucoside (UNII: 6JVW35JOOJ)
docosanol (UNII: 9G1OE216XY)
butylene glycol (UNII: 3XUS85K0RA)
shea butter (UNII: K49155WL9Y)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 6 (UNII: 481744AI4O)
ethylhexyl palmitate (UNII: 2865993309)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
panthenyl ethyl ether (UNII: F4WMF8NX3B)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
high density polyethylene (UNII: UG00KM4WR7)
PPG-5-ceteth-20 (UNII: 4AAN25P8P4)
ferric oxide red (UNII: 1K09F3G675)
titanium dioxide (UNII: 15FIX9V2JP)
phenyl trimethicone (UNII: DR0K5NOJ4R)
grape seed oil (UNII: 930MLC8XGG)
castor oil (UNII: D5340Y2I9G)
sandalwood (UNII: 3641YW25N2)
saccharin (UNII: FST467XS7D)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.69 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/31/2013

Part 2 of 3

BLISTEX   SILK AND SHINE
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
arachidyl alcohol (UNII: 1QR1QRA9BU)
arachidyl glucoside (UNII: 6JVW35JOOJ)
docosanol (UNII: 9G1OE216XY)
mica (UNII: V8A1AW0880)
microcrystalline wax (UNII: XOF597Q3KY)
mineral oil (UNII: T5L8T28FGP)
panthenyl ethyl ether (UNII: F4WMF8NX3B)
paraffin (UNII: I9O0E3H2ZE)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
petrolatum (UNII: 4T6H12BN9U)
phenoxyethanol (UNII: HIE492ZZ3T)
phenyl trimethicone (UNII: DR0K5NOJ4R)
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)
saccharin (UNII: FST467XS7D)
titanium dioxide (UNII: 15FIX9V2JP)
sandalwood (UNII: 3641YW25N2)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
Ceresin (UNII: Q1LS2UJO3A)
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.69 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/01/2012

Part 3 of 3

BLISTEX   DEEP RENEWAL
avobenzone, octinoxate, octocrylene, oxybenzone, and dimethicone 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
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
yellow wax (UNII: 2ZA36H0S2V)
butylene glycol (UNII: 3XUS85K0RA)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
ethylhexyl palmitate (UNII: 2865993309)
lanolin alcohols (UNII: 884C3FA9HE)
microcrystalline wax (UNII: XOF597Q3KY)
octyldodecanol (UNII: 461N1O614Y)
pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)
petrolatum (UNII: 4T6H12BN9U)
phenoxyethanol (UNII: HIE492ZZ3T)
high density polyethylene (UNII: UG00KM4WR7)
polytetrafluoroethylene (UNII: E1NC1JVS3O)
castor oil (UNII: D5340Y2I9G)
saccharin (UNII: FST467XS7D)
silica dimethyl silylate (UNII: EU2PSP0G0W)
hyaluronate sodium (UNII: YSE9PPT4TH)
sorbic acid (UNII: X045WJ989B)
squalane (UNII: GW89575KF9)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
CHONDROITIN SULFATE SODIUM (SHARK) (UNII: Q75WVO004L)
UBIDECARENONE (UNII: EJ27X76M46)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3.69 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	11/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/15/2014

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9858)