BLISTEX ENHANCEMENT SERIES (SOFT AND LUSH, DEEP RENEWAL AND ULTRA-RICH HYDRATION)- 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.

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Blistex® Enhancement Series® (Soft and Lush®, Deep Renewal® and Ultra-Rich Hydration®)

SOFT & LUSH®

Drug Facts

Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (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

alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, hydrogenated castor oil, hydrogenated polyisobutene, isopropyl myristate, microcrystalline wax, paraffin, PEG-8, PEG-60 hydrogenated castor oil, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, silica, titanium dioxide

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

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 (decolorized), 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

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

soft • youthful • smooth

BUY 2 GET 1 FREE

NEW!

BROAD SPECTRUM
SPF15
SPF15
SPF15

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

Principal Display Panel - Kit Blister Pack
BLISTEX ENHANCEMENT SERIES (SOFT AND LUSH, DEEP RENEWAL AND ULTRA-RICH HYDRATION) 
dimethicone, octinoxate, oxybenzone, avobenzone and octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9867
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9867-11 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 SOFT AND LUSH 
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
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
PETROLATUM (UNII: 4T6H12BN9U)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CERESIN (UNII: Q1LS2UJO3A)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
CERAMIDE 2 (UNII: C04977SRJ5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SACCHARIN (UNII: FST467XS7D)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
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 FINALpart34708/01/2015
Part 2 of 3
BLISTEX DEEP RENEWAL 
dimethicone, octinoxate, oxybenzone, avobenzone, and octocrylene 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; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/01/2015
Part 3 of 3
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 FINALpart34708/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34707/01/2015
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9867)

Revised: 8/2015
Document Id: 99cd258c-beda-478e-b99b-75b9f41ffa78
Set id: b3eae6b7-0705-4521-8ecc-bef01373b0bf
Version: 1
Effective Time: 20150828
 
Blistex Inc.