Blistex

Manufacturer: Blistex Inc.
Effective date: 2013-03-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:35

Label at a glance#

ProductBlistex Lip Vibrance

Active ingredientOctinoxate, Oxybenzone, Dimethicone

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 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
Octinoxate 7.5% (w/w)	Sunscreen
Oxybenzone 2.5% (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.

OTC - DO NOT USE SECTION

For external use only

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

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bis-diglyceryl polyacyladipate-2, butylene glycol, butyrospermum parkii (shea butter), D&C red no. 6, D&C red no. 7, ethylhexyl palmitate, flavors, hydrogenated polyisobutene, iron oxides, isostearoyl hydrolyzed silk, mica, microcrystalline wax, mineral oil, ozokerite, panthenyl ethyl ether, paraffin, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, phenyl trimethicone, polybutene, polyethylene, PPG-5-ceteth-20, ricinus communis (castor) seed oil, saccharin, silica dimethyl silylate, sodium hyaluronate, titanium dioxide, tocopheryl acetate, vitis vinifera (grape) seed oil

Other information

STORAGE AND HANDLING SECTION

protect the product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 3.69g Container Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9831-1
Blistex _®
LIP PROTECTANT/SUNSCREEN

LIP
VIBRANCE_™

New!

A Touch Of Color & Shimmer
That Really Lasts

Rich Moisturization & Protection

Total Care For Your Lips' Complexion

SPF 15

Built-in Mirror

NET WT. .13 oz (3.69g)

PRINCIPAL DISPLAY PANEL - 3.69g Container 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
10157-9831-1	2020-01-31	C162847	48780-1	9d75b9d0-b419-f424-e053-dadaa90a57ce	Blistex ® Lip Vibrance ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10157-9831-1	Blistex Lip Vibrance	3.69 g in 1 CYLINDER	STICK	3.69		1
10157-9831-1	Blistex Lip Vibrance	1 in 1 BLISTER PACK	STICK	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10157-9831	BLISTEX LIP VIBRANCE (OCTINOXATE, OXYBENZONE, AND DIMETHICONE) STICK [BLISTEX INC.]	1	Legacy NDC, 2 package rows	20130531_efc150e3-56e9-45bb-9064-951d5f665682.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
arachidyl alcohol	INACTIVE INGREDIENT	1QR1QRA9BU	1
arachidyl glucoside	INACTIVE INGREDIENT	6JVW35JOOJ	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	1
ceresin	INACTIVE INGREDIENT	Q1LS2UJO3A	1
D&C red no. 6	INACTIVE INGREDIENT	481744AI4O	1
D&C red no. 7	INACTIVE INGREDIENT	ECW0LZ41X8	1
docosanol	INACTIVE INGREDIENT	9G1OE216XY	1
ethylhexyl palmitate	INACTIVE INGREDIENT	2865993309	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
grape seed oil	INACTIVE INGREDIENT	930MLC8XGG	1
high density polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
hyaluronate sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
panthenyl ethyl ether	INACTIVE INGREDIENT	F4WMF8NX3B	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
pentaerythrityl tetraethylhexanoate	INACTIVE INGREDIENT	XJ7052W897	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
phenyl trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	1
PPG-5-ceteth-20	INACTIVE INGREDIENT	4AAN25P8P4	1
saccharin	INACTIVE INGREDIENT	FST467XS7D	1
sandalwood	INACTIVE INGREDIENT	3641YW25N2	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	1
silica dimethyl silylate	INACTIVE INGREDIENT	EU2PSP0G0W	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

Blistex Lip Vibrance
Octinoxate, Oxybenzone, and Dimethicone
Octinoxate
Oxybenzone
Dimethicone
arachidyl alcohol
arachidyl glucoside
docosanol
butylene glycol
shea butter
D&C red no. 6
D&C red no. 7
ethylhexyl palmitate
mica
microcrystalline wax
mineral oil
panthenyl ethyl ether
paraffin
pentaerythrityl tetraethylhexanoate
petrolatum
phenoxyethanol
phenyl trimethicone
high density polyethylene
PPG-5-ceteth-20
castor oil
saccharin
silica dimethyl silylate
hyaluronate sodium
titanium dioxide
.alpha.-tocopherol acetate
grape seed oil
ferric oxide red
ceresin
sandalwood

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10157-9831	10157-9831-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Dimethicone	92RU3N3Y1O	ACTIB
arachidyl alcohol	1QR1QRA9BU	IACT
arachidyl glucoside	6JVW35JOOJ	IACT
docosanol	9G1OE216XY	IACT
butylene glycol	3XUS85K0RA	IACT
shea butter	K49155WL9Y	IACT
D&C red no. 6	481744AI4O	IACT
D&C red no. 7	ECW0LZ41X8	IACT
ethylhexyl palmitate	2865993309	IACT
mica	V8A1AW0880	IACT
microcrystalline wax	XOF597Q3KY	IACT
mineral oil	T5L8T28FGP	IACT
panthenyl ethyl ether	F4WMF8NX3B	IACT
paraffin	I9O0E3H2ZE	IACT
pentaerythrityl tetraethylhexanoate	XJ7052W897	IACT
petrolatum	4T6H12BN9U	IACT
phenoxyethanol	HIE492ZZ3T	IACT
phenyl trimethicone	DR0K5NOJ4R	IACT
high density polyethylene	UG00KM4WR7	IACT
PPG-5-ceteth-20	4AAN25P8P4	IACT
castor oil	D5340Y2I9G	IACT
saccharin	FST467XS7D	IACT
silica dimethyl silylate	EU2PSP0G0W	IACT
hyaluronate sodium	YSE9PPT4TH	IACT
titanium dioxide	15FIX9V2JP	IACT
.alpha.-tocopherol acetate	9E8X80D2L0	IACT
grape seed oil	930MLC8XGG	IACT
ferric oxide red	1K09F3G675	IACT
ceresin	Q1LS2UJO3A	IACT
sandalwood	3641YW25N2	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 4 · 209 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		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
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
silica dimethyl silylate	SILICA DIMETHYL SILYLATE	EU2PSP0G0W	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
docosanol	DOCOSANOL	9G1OE216XY	SOLUTION / TOPICAL	1.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
saccharin	SACCHARIN	FST467XS7D	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
microcrystalline wax	MICROCRYSTALLINE WAX	XOF597Q3KY	CREAM / VAGINAL		23 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
saccharin	SACCHARIN	FST467XS7D	DROPS / ORAL	20 mg/1ml		Exact identifier — unii candidate 16 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
silica dimethyl silylate	SILICA DIMETHYL SILYLATE	EU2PSP0G0W	CAPSULE / ORAL	0.5 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	CAPSULE, EXTENDED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
saccharin	SACCHARIN	FST467XS7D	SYRUP / ORAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
hyaluronate sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
ceresin	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 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
4365e238-9de4-4d27-98ce-c684f33b61bd			efc150e3-56e9-45bb-9064-951d5f665682	2013-03-26	Warnings	Exact identifier spl id: 4365e238-9de4-4d27-98ce-c684f33b61bd spl set id: efc150e3-56e9-45bb-9064-951d5f665682

Reported adverse events (FAERS/openFDA)#

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