Blistex

Manufacturer: Blistex Inc.
Effective date: 2018-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:57:20

Label at a glance#

ProductBlistex Medicated Lip Balm

Active ingredientDimethicone, Oxybenzone, Padimate O

Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Dimethicone 2.0% (w/w)	Lip protectant
Oxybenzone 2.5% (w/w)	Sunscreen
Padimate O 6.6% (w/w)	Sunscreen

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve chapped or cracked lips
helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistex_® MEDICATED LIP BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

Blistex_® MEDICATED LIP BALM
NET WT. .15 oz (4.25g)

SPF 15

Blistex_® MEDICATED LIP BALM

DO NOT USE IF SEAL IS MISSING.

Lift for Drug Facts

Principal Display Panel - 4.25 g Cylinder Blister Pack

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10157-9822-3	2020-01-31	C162847	48780-1	9d75b9d0-6466-f424-e053-dadaa90a57ce	Blistex ® Medicated Lip Balm
10157-9822-4	2020-01-31	C162847	48780-1	9d75b9d0-6466-f424-e053-dadaa90a57ce	Blistex ® Medicated Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10157-9822-1	Blistex Medicated Lip Balm	4.25 g in 1 CYLINDER	STICK	4.25	2
10157-9822-3	Blistex Medicated Lip Balm	3 in 1 BLISTER PACK	STICK	3	2
10157-9822-4	Blistex Medicated Lip Balm	4 in 1 BLISTER PACK	STICK	4	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10157-9822	BLISTEX MEDICATED LIP BALM (DIMETHICONE, OXYBENZONE, AND PADIMATE O) STICK [BLISTEX INC.]	2	Legacy NDC, 3 package rows	20181121_eb1659da-6f14-4b94-9ac1-2c29338a8d1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Padimate O	ACTIVE INGREDIENT	Z11006CMUZ	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
Padimate O	ACTIVE MOIETY	Z11006CMUZ	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	1
cocoa butter	INACTIVE INGREDIENT	512OYT1CRR	1
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	1
isopropyl stearate	INACTIVE INGREDIENT	43253ZW1MZ	1
lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
lanolin oil	INACTIVE INGREDIENT	OVV5IIJ58F	1
menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
polybutene (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

Blistex Medicated Lip Balm
Dimethicone, Oxybenzone, and Padimate O
Dimethicone
Oxybenzone
Padimate O
yellow wax
cetyl alcohol
cetyl palmitate
candelilla wax
isopropyl myristate
isopropyl palmitate
isopropyl stearate
lanolin
lanolin oil
menthol, unspecified form
methylparaben
mineral oil
paraffin
petrolatum
polybutene (1400 MW)
propylparaben
D&C Red No. 6
aluminum oxide
cocoa butter
titanium dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10157-9822	10157-9822-1, 10157-9822-3, 10157-9822-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Padimate O	Z11006CMUZ	ACTIB
yellow wax	2ZA36H0S2V	IACT
cetyl alcohol	936JST6JCN	IACT
cetyl palmitate	5ZA2S6B08X	IACT
candelilla wax	WL0328HX19	IACT
isopropyl myristate	0RE8K4LNJS	IACT
isopropyl palmitate	8CRQ2TH63M	IACT
isopropyl stearate	43253ZW1MZ	IACT
lanolin	7EV65EAW6H	IACT
lanolin oil	OVV5IIJ58F	IACT
menthol, unspecified form	L7T10EIP3A	IACT
methylparaben	A2I8C7HI9T	IACT
mineral oil	T5L8T28FGP	IACT
paraffin	I9O0E3H2ZE	IACT
petrolatum	4T6H12BN9U	IACT
polybutene (1400 MW)	1NA5AO9GH7	IACT
propylparaben	Z8IX2SC1OH	IACT
D&C Red No. 6	481744AI4O	IACT
aluminum oxide	LMI26O6933	IACT
cocoa butter	512OYT1CRR	IACT
titanium dioxide	15FIX9V2JP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 349 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
candelilla wax	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
lanolin oil	LANOLIN OIL	OVV5IIJ58F	CREAM / TOPICAL		143 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
menthol	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
yellow wax	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fc240f26-6278-4122-babc-34a0193aff91			eb1659da-6f14-4b94-9ac1-2c29338a8d1d	2018-11-20	Warnings	Exact identifier spl id: fc240f26-6278-4122-babc-34a0193aff91 spl set id: eb1659da-6f14-4b94-9ac1-2c29338a8d1d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.