BLISTEX ENHANCEMENT SERIES- dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene 
Blistex Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Blistex®
Enhancement Series®

DEEP RENEWAL®

Drug Facts

Active ingredientsPurpose
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

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

Other information

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

LIP VIBRANCE®

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

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

Other information

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

SILK & SHINE®

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 7.5% (w/w)Sunscreen
Oxybenzone 2.5% (w/w)Sunscreen

Uses

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

Other information

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

Principal Display Panel - 3 Stick Blister Pack
BLISTEX  ENHANCEMENT SERIES
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9858
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9858-11 in 1 BLISTER PACK
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CYLINDER 3.69 g
Part 21 CYLINDER 3.69 g
Part 31 CYLINDER 3.69 g
Part 1 of 3
BLISTEX   LIP VIBRANCE
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/31/2013
Part 2 of 3
BLISTEX   SILK AND SHINE
dimethicone, octinoxate, and oxybenzone stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2012
Part 3 of 3
BLISTEX   DEEP RENEWAL
avobenzone, octinoxate, octocrylene, oxybenzone, and dimethicone stick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone2 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2.5 g  in 100 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
13.69 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/15/2014
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9858)

Revised: 4/2014
Document Id: 78ad38e1-bf7d-43dd-8c57-e37864ce7334
Set id: 710477dc-7611-4611-8769-3b658b8addc6
Version: 1
Effective Time: 20140423
 
Blistex Inc.