ENHANCEMENT SERIES (BLISTEX DEEP RENEWAL BROAD SPECTRUM, BLISTEX MOISTURE REVITALIZER, BLISTEX SOFT AND LUSH)- avobenzone, octinoxate, octisalate, and dimethicone kit

Enhancement Series (Blistex Deep Renewal Broad Spectrum, Blistex Moisture Revitalizer, Blistex Soft and Lush) by

Drug Labeling and Warnings

Enhancement Series (Blistex Deep Renewal Broad Spectrum, Blistex Moisture Revitalizer, Blistex Soft and Lush) 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 6.6% (w/w)	Sunscreen
Octisalate 4.4% (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, flavors, jojoba esters, lanolin alcohol, microcrystalline wax, octyldodecanol, pentaerythrityl tetraisostearate, pentylene glycol, petrolatum, phenoxyethanol, polybutene, 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

MOISTURE REVITALIZER™

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Dimethicone 3.0% (w/w)	Lip protectant
Octinoxate 6.6% (w/w)	Sunscreen
Octisalate 4.4% (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

alumina, butylene glycol, C12-15 alkyl benzoate, caprylic/capric triglyceride, ceramide NG, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavors, isopropyl myristate, linoleic acid, linolenic acid, microcrystalline wax, myristyl myristate, ozokerite, palmitoyl hexapeptide-12, petrolatum, phenoxyethanol, polybutene, polyhydroxystearic acid, saccharin, silica dimethyl silylate, sodium hyaluronate, sorbic acid, stearic acid, titanium dioxide, tocopherol, tocopheryl acetate, tribehenin, tridecyl neopentanoate

SPL UNCLASSIFIED SECTION

SOFT & LUSH®

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Dimethicone 2.0% (w/w)	Lip protectant
Octinoxate 6.6% (w/w)	Sunscreen
Octisalate 4.4% (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

alumina, arachidyl alcohol, arachidyl glucoside, beeswax, behenyl alcohol, bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, C12-15 alkyl benzoate, caprylic/capric triglyceride, ceramide NG, ceresin, cetyl dimethicone, cetyl palmitate, flavors, glyceryl laurate, hydrogenated castor oil, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, palmitoyl hexapeptide-12, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polyhydroxystearic acid, saccharin, stearic acid, titanium dioxide, tribehenin

PRINCIPAL DISPLAY PANEL - Kit Blister Pack

Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

youthful hydrated soft

BUY 2 GET 1 FREE

BROAD SPECTRUM
SPF15

NEW!
SPF15

SPF15

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

INGREDIENTS AND APPEARANCE

ENHANCEMENT SERIES (BLISTEX DEEP RENEWAL BROAD SPECTRUM, BLISTEX MOISTURE REVITALIZER, BLISTEX SOFT AND LUSH) 
avobenzone, octinoxate, octisalate, and dimethicone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9906

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9906-1	1 in 1 BLISTER PACK	08/26/2019

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

DEEP RENEWAL BROAD SPECTRUM 
dimethicone, avobenzone, octinoxate, and octisalate 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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
CHONDROITIN SULFATE SODIUM, SHARK (UNII: Q75WVO004L)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN (UNII: FST467XS7D)
SORBIC ACID (UNII: X045WJ989B)

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	08/26/2019

Part 2 of 3

MOISTURE REVITALIZER 
dimethicone, avobenzone, and octinoxate stick

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	6.6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
CERESIN (UNII: Q1LS2UJO3A)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
PETROLATUM (UNII: 4T6H12BN9U)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CERAMIDE NG (UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
ORANGE (UNII: 5EVU04N5QU)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LINOLENIC ACID (UNII: 0RBV727H71)
TOCOPHEROL (UNII: R0ZB2556P8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARIN (UNII: FST467XS7D)
SORBIC ACID (UNII: X045WJ989B)

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	08/26/2019

Part 3 of 3

SOFT AND LUSH 
dimethicone, octinoxate, and octisalate 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	6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
PETROLATUM (UNII: 4T6H12BN9U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CERESIN (UNII: Q1LS2UJO3A)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
WHITE WAX (UNII: 7G1J5DA97F)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
GLYCERYL LAURATE (UNII: Y98611C087)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CERAMIDE NG (UNII: C04977SRJ5)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

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	part352	08/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/26/2019

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-9906)