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

LIP MEDEX®

Drug Facts

Active ingredientsPurpose
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

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

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

MEDICATED
LIP OINTMENT

Drug Facts

Active ingredientsPurpose
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

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

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

FIVE STAR
LIP PROTECTION®

Drug Facts

Active ingredientsPurpose
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

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

Other information

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

COMPLETE MOISTURE®

Drug Facts

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

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.

PRINCIPAL DISPLAY PANEL - Blister Pack Kit
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:10157-9904
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10157-9904-11 in 1 BLISTER PACK11/20/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 JAR 7.08 g
Part 21 TUBE 6 g
Part 31 CYLINDER 4.25 g
Part 41 CYLINDER 4.25 g
Part 1 of 4
BLISTEX LIP MEDEX 
petrolatum, menthol, unspecified form, camphor (synthetic), and phenol paste
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM59.14 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 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) PHENOL0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
17.08 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/20/2018
Part 2 of 4
BLISTEX MEDICATED LIP 
dimethicone, camphor (synthetic), menthol, unspecified form, and phenol ointment
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.1 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 FORM0.625 g  in 100 g
Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
16 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/20/2018
Part 3 of 4
BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM 
dimethicone, avobenzone, homosalate, octinoxate, and octisalate 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
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/20/2018
Part 4 of 4
BLISTEX COMPLETE MOISTURE 
dimethicone, octinoxate, and octisalate 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) OCTINOXATE6.6 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/20/2018
Labeler - Blistex Inc. (005126354)
Establishment
NameAddressID/FEIBusiness Operations
Blistex Inc.005126354MANUFACTURE(10157-9904)

Revised: 12/2018
Document Id: cac1566d-e74f-4c9d-9bf3-25ae8086900d
Set id: ad45a5d1-0589-4857-ab39-9a02e15f3164
Version: 1
Effective Time: 20181207
 
Blistex Inc.