BLISTEX COMPLETE CARE (BLISTEX LIP MEDEX, BLISTEX MEDICATED LIP, BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM, AND BLISTEX COMPLETE MOISTURE) (petrolatum, menthol, unspecified form, camphor- synthetic, phenol, dimethicone, avobenzone, homosalate, octinoxate, and octisalate kit

Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture) by

Drug Labeling and Warnings

Blistex Complete Care (Blistex Lip Medex, Blistex Medicated Lip, Blistex Five Star Lip Protection Broad Spectrum, and Blistex Complete Moisture) by is a Otc medication manufactured, distributed, or labeled by Blistex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIP MEDEX®

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 1.0% (w/w)	External analgesic
Menthol 1.0% (w/w)	External analgesic
Petrolatum 59.14% (w/w)	Lip protectant
Phenol 0.54% (w/w)	External analgesic

Uses

• for the temporary relief of pain and itching associated with minor lip irritation
• temporarily protects and helps relieve chapped or cracked lips
• helps protect lips from the drying effects of wind and cold weather

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes
• do not apply over large areas of the body or bandage

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: Consult a doctor

Inactive ingredients

beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

SPL UNCLASSIFIED SECTION

MEDICATED
LIP OINTMENT

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 0.5% (w/w)	External analgesic
Dimethicone 1.1% (w/w)	Lip protectant
Menthol 0.625% (w/w)	External analgesic
Phenol 0.5% (w/w)	External analgesic

Uses

• for the temporary relief of pain and itching associated with minor lip irritation or cold sores
• temporarily protects and helps relieve chapped or cracked lips

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes
• do not apply over large areas of the body or bandage

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: Consult a doctor

Inactive ingredients

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

SPL UNCLASSIFIED SECTION

FIVE STAR
LIP PROTECTION®

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0% (w/w)	Sunscreen
Dimethicone 2.0% (w/w)	Lip protectant
Homosalate 10.0% (w/w)	Sunscreen
Octinoxate 7.5% (w/w)	Sunscreen
Octisalate 5.0% (w/w)	Sunscreen

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

bis-diglyceryl polyacyladipate-2, bis-stearyl dimethicone, calendula officinalis flower extract, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, citric acid, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, microcrystalline wax, myristyl myristate, octyldodecanol, ozokerite, panthenol, phenoxyethanol, sorbic acid, stearyl behenate, sucralose, tetrahexyldecyl ascorbate, tocopheryl acetate, triticum vulgare (wheat) germ oil

SPL UNCLASSIFIED SECTION

COMPLETE MOISTURE®

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

behenoyl stearic acid, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, diethylhexyl adipate, ethylhexyl palmitate, ethylhexyl stearate, flavor, glycerin, hydrogenated phosphatidylcholine, jojoba esters, microcrystalline wax, ozokerite, panthenol, petrolatum, phenoxyethanol, purified water, sodium borate, sodium saccharin, squalane

PRINCIPAL DISPLAY PANEL - Blister Pack Kit

Blistex®

COMPLETE MOISTURE & FIVE STAR: LIP PROTECTANT/SUNSCREEN
LIP OINTMENT & LIP MEDEX: LIP PROTECTANT/EXTERNAL ANALGESIC

PROTECT MOISTURIZE RELIEVE

BUY 3 GET 1 BONUS

1 Jar Net Wt. 0.25 oz (7.08 g)
1 Tube Net Wt. 0.21 oz. (6 g)

2 Sticks Net Wt. 0.15 oz.
(4.25 g) ea.

INGREDIENTS AND APPEARANCE

BLISTEX COMPLETE CARE (BLISTEX LIP MEDEX, BLISTEX MEDICATED LIP, BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM, AND BLISTEX COMPLETE MOISTURE) 
petrolatum, menthol, unspecified form, camphor (synthetic), phenol, dimethicone, avobenzone, homosalate, octinoxate, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-9904

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-9904-1	1 in 1 BLISTER PACK	11/20/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 JAR	7.08 g
Part 2	1 TUBE	6 g
Part 3	1 CYLINDER	4.25 g
Part 4	1 CYLINDER	4.25 g

Part 1 of 4

BLISTEX LIP MEDEX 
petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	59.14 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1 g  in 100 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)
SACCHARIN (UNII: FST467XS7D)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.08 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/20/2018

Part 2 of 4

BLISTEX MEDICATED LIP 
dimethicone, camphor (synthetic), menthol, unspecified form, and phenol ointment

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	1.1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.5 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.625 g  in 100 g
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV)	Phenol	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
PARAFFIN (UNII: I9O0E3H2ZE)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PALMITIC ACID (UNII: 2V16EO95H1)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)
LAURIC ACID (UNII: 1160N9NU9U)
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLEIC ACID (UNII: 2UMI9U37CP)
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/20/2018

Part 3 of 4

BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM 
dimethicone, avobenzone, homosalate, 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
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	10 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Microcrystalline Wax (UNII: XOF597Q3KY)
Octyldodecanol (UNII: 461N1O614Y)
Ceresin (UNII: Q1LS2UJO3A)
Myristyl Myristate (UNII: 4042ZC00DY)
Stearyl Behenate (UNII: A68S9UI39D)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
WHEAT GERM OIL (UNII: 14C97E680P)
SAFFLOWER OIL (UNII: 65UEH262IS)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4.25 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	11/20/2018

Part 4 of 4

BLISTEX COMPLETE MOISTURE 
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
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIETHYLHEXYL ADIPATE (UNII: MBY1SL921L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
SODIUM BORATE (UNII: 91MBZ8H3QO)
PANTHENOL (UNII: WV9CM0O67Z)
SQUALANE (UNII: GW89575KF9)
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 07PS463G0H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4.25 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	11/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/20/2018

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-9904)