Search by Drug Name or NDC

NDC 10157-9905-01 Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) Details

Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother)

Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is .

Product Information

NDC	10157-9905
Product ID	10157-9905_53e1a3de-8e68-4408-8e11-510a969d60ba
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother)
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone, Octinoxate, Octisalate, Avobenzone, and Homosalate
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Blistex Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 10157-9905-01 (10157990501)

Pricing Information	N/A
NDC Package Code	10157-9905-1
Billing NDC	10157990501
Package	1 KIT in 1 CARTON (10157-9905-1) * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER * 4.25 g in 1 CYLINDER
Marketing Start Date	2019-08-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL db6baf1f-b359-4f70-b597-5a3c3549c041 Details

SPL UNCLASSIFIED SECTION

FIVE STAR Lip Protection®

Drug Facts

SPL UNCLASSIFIED SECTION

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® SPF 15 MEDICATED BALM SPF 15 SUPERFRUIT SOOTHER® SPF 15

Drug Facts

SPL UNCLASSIFIED SECTION

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

COMPLETE MOISTURE 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

MEDICATED BALM Inactive ingredients

beeswax, camphor, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavor, isopropyl myristate, lanolin, lanolin oil, menthol, methyl salicylate, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, theobroma cacao (cocoa) seed butter, titanium dioxide

SUPERFRUIT SOOTHER Inactive ingredients

beeswax, caprylic/capric triglyceride, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, euterpe oleracea (acai) fruit extract, flavor, isopropyl myristate, lanolin, lanolin oil, menthoxypropanediol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, rubus chamaemorus (cloudberry) fruit extract, saccharin, tetrahexyldecyl ascorbate, theobroma cacao (cocoa) seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - Kit Carton

Blistex®

LIP PROTECTANT/SUNSCREEN

ADVANCED CARE

VALUE PACK

Dial Up Your Lip Care

Buy 3 Upgrades

Power

Protection

Ultra

Moisturizing

Super

Soothing

Get 1

Classic

FREE

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

INGREDIENTS AND APPEARANCE

BLISTEX ADVANCED CARE (BLISTEX MEDICATED BALM, BLISTEX COMPLETE MOISTURE, BLISTEX FIVE STAR LIP BALM - BROAD SPECTRUM, BLISTEX SUPERFRUIT SOOTHER)

dimethicone, octinoxate, octisalate, avobenzone, and homosalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-9905

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10157-9905-1	1 in 1 CARTON	08/26/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CYLINDER	4.25 g
Part 2	1 CYLINDER	4.25 g
Part 3	1 CYLINDER	4.25 g
Part 4	1 CYLINDER	4.25 g

Part 1 of 4
BLISTEX MEDICATED LIP BALM dimethicone, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
LANOLIN OIL (UNII: OVV5IIJ58F)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O)
METHYL SALICYLATE (UNII: LAV5U5022Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

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

Part 2 of 4
BLISTEX COMPLETE MOISTURE dimethicone, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/26/2019

Part 3 of 4
BLISTEX FIVE STAR LIP PROTECTION BROAD SPECTRUM dimethicone, avobenzone, homosalate, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

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

Part 4 of 4
BLISTEX SUPERFRUIT SOOTHER dimethicone, octinoxate, and octisalate stick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN OIL (UNII: OVV5IIJ58F)
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
CANDELILLA WAX (UNII: WL0328HX19)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ACAI (UNII: 46AM2VJ0AW)
RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)
PARAFFIN (UNII: I9O0E3H2ZE)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
SACCHARIN (UNII: FST467XS7D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

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

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

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-9905)

Revised: 8/2019

Document Id: 53e1a3de-8e68-4408-8e11-510a969d60ba

Set id: db6baf1f-b359-4f70-b597-5a3c3549c041

Version: 1

Effective Time: 20190829

Search by Drug Name or NDC

NDC 10157-9905-01 Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother) Details

Blistex Advanced Care (Blistex Medicated Balm, Blistex Complete Moisture, Blistex Five Star Lip Balm - Broad Spectrum, Blistex Superfruit Soother)

Product Information

Package

Package Images

NDC 10157-9905-01 (10157990501)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL db6baf1f-b359-4f70-b597-5a3c3549c041 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Skin Cancer/Skin Aging Alert

Directions

Other information

COMPLETE MOISTURE Inactive ingredients

MEDICATED BALM Inactive ingredients

SUPERFRUIT SOOTHER Inactive ingredients

PRINCIPAL DISPLAY PANEL - Kit Carton

INGREDIENTS AND APPEARANCE

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