BLISTEX ENHANCEMENT SERIES (DEEP RENEWAL AND SILK AND SHINE)- avobenzone, dimethicone, octinoxate, octocrylene and oxybenzone kit

Blistex Enhancement Series (Deep Renewal and Silk and Shine) by

Drug Labeling and Warnings

Blistex Enhancement Series (Deep Renewal and Silk and Shine) 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 in this container 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

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 in this container 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 - Kit Blister Pack

NDC: 10157-9865-1

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

VALUE PACK
Anti-aging rejuvenation
Satiny smooth & light shine

BROAD SPECTRUM SPF 15

2 Sticks Net Wt. 0.13 oz. (3.69 g) Ea.

SPF 15

INGREDIENTS AND APPEARANCE

BLISTEX ENHANCEMENT SERIES (DEEP RENEWAL AND SILK AND SHINE) 
avobenzone, dimethicone, octinoxate, octocrylene and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9865

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9865-1	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 1 of 2

BLISTEX DEEP RENEWAL 
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene 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; Type 0: Not a Combination Product

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

Part 2 of 2

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; Type 0: Not a Combination Product

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	02/01/2015

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9865)