BLISTEX ENHANCEMENT SERIES (ULTRA-RICH HYDRATION AND LIP VIBRANCE)- dimethicone, octinoxate and oxybenzone 
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.

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Blistex® Enhancement Series® (Ultra-Rich Hydration™ and Lip Vibrance®)

ULTRA-RICH HYDRATION™

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.8% (w/w)Sunscreen
Oxybenzone 3.0% (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

aloe barbadensis leaf extract, alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, blue 1 lake, butyrospermum parkii (shea butter), ceresin, cetyl dimethicone, cetyl palmitate, chamomilla recutita (matricaria) flower extract, flavors, helianthus annuus (sunflower) seed oil, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, isostearoyl hydrolyzed silk, jojoba esters, microcrystalline wax, olea europaea (olive) fruit oil, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, theobroma cacao (cocoa) seed butter, titanium dioxide, tocopheryl acetate, triticum vulgare (wheat) germ oil

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

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

NDC 10157-9866-1

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

VALUE PACK

Dual-layer deep hydration

A touch of color & total care

SPF 15

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

SPF 15

Principal Display Panel - Kit Blister Pack
BLISTEX ENHANCEMENT SERIES (ULTRA-RICH HYDRATION AND LIP VIBRANCE) 
dimethicone, octinoxate and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9866
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9866-11 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 1 of 2
BLISTEX ULTRA-RICH HYDRATION 
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) Octinoxate6.8 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
yellow wax (UNII: 2ZA36H0S2V)  
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)  
petrolatum (UNII: 4T6H12BN9U)  
paraffin (UNII: I9O0E3H2ZE)  
hydrogenated castor oil (UNII: ZF94AP8MEY)  
microcrystalline wax (UNII: XOF597Q3KY)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
titanium dioxide (UNII: 15FIX9V2JP)  
shea butter (UNII: K49155WL9Y)  
aluminum oxide (UNII: LMI26O6933)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
arachidyl alcohol (UNII: 1QR1QRA9BU)  
docosanol (UNII: 9G1OE216XY)  
arachidyl glucoside (UNII: 6JVW35JOOJ)  
olive oil (UNII: 6UYK2W1W1E)  
aloe vera leaf (UNII: ZY81Z83H0X)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
wheat germ oil (UNII: 14C97E680P)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
sunflower oil (UNII: 3W1JG795YI)  
chamomile (UNII: FGL3685T2X)  
ceresin (UNII: Q1LS2UJO3A)  
cocoa butter (UNII: 512OYT1CRR)  
saccharin (UNII: FST467XS7D)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13.69 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/30/2014
Part 2 of 2
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; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34705/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/01/2015
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9866)

Revised: 12/2014
Document Id: 650478de-15c3-4326-b2f3-1582c4e8a731
Set id: 3154835b-ce91-45d8-b6df-cad59b3d7d27
Version: 1
Effective Time: 20141204
 
Blistex Inc.