Blistex

Manufacturer
Blistex Inc.
Effective date
2012-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:31:12

Label at a glance#

ProductBlistex European Formula
Active ingredientLanolin, Octinoxate, Oxybenzone
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps protect lips from the drying effects of wind and cold weather helps prevent sunburn

Dosage and administration

apply liberally before sun exposure and as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lanolin 13 .0%(w/w)Skin 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 protect lips from the drying effects of wind and cold weather
  • helps prevent sunburn

Warnings

WARNINGS SECTION

  • Stop use if skin rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally before sun exposure and as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, camphor, cetyl alcohol, cocoyl hydrolyzed soy protein, euphorbia cerifera (candelilla) wax, fragrance, isostearoyl hydrolyzed collagen, menthol, microcrystalline wax, olea europaea (olive) fruit oil, petrolatum, saccharin, theobroma cacao (cocoa) seed butter, thymol, tocopheryl acetate, vanillin, vitis vinifera (grape) seed oil

SPL UNCLASSIFIED SECTION

#34280
©2011 Blistex Inc.,
P.O. Box 5392,
Oak Brook, IL 60522-5392

PRINCIPAL DISPLAY PANEL - 7 g Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9539-1

Blistex®

LIP PROTECTANT/
SUNSCREEN

SPF
15

EUROPEAN FORMULA
LIP CONDITIONER
™

Moisturizes & Protects For Healthy, Beautiful Lips

Enriched with Olive & Grapeseed Oils,
Vitamin E, Cocoa Butter, Lanolin and Collagen

NET WT. .25 oz (7g)

Principal Display Panel - 7 g Container Label
Principal Display Panel - 7 g Container Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-9539-12019-11-13C16284748780-197449f38-bed0-f6ea-e053-dbdaa90aa703Blistex ® European Formula Lip Conditioner™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9539-1Blistex European Formula7 g in 1 JARPASTE72
10157-9539-1Blistex European Formula1 in 1 BLISTER PACKPASTE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9539BLISTEX EUROPEAN FORMULA (LANOLIN, OCTINOXATE, AND OXYBENZONE) PASTE [BLISTEX INC.]2Legacy NDC, 2 package rows20120319_197a2d5b-cd4b-431e-940b-f76684db7451.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LanolinACTIVE INGREDIENT7EV65EAW6H2
OctinoxateACTIVE INGREDIENT4Y5P7MUD512
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y2
LanolinACTIVE MOIETY7EV65EAW6H2
OctinoxateACTIVE MOIETY4Y5P7MUD512
OxybenzoneACTIVE MOIETY95OOS7VE0Y2
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L02
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X2
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ET2
candelilla waxINACTIVE INGREDIENTWL0328HX192
cetyl alcoholINACTIVE INGREDIENT936JST6JCN2
cocoa butterINACTIVE INGREDIENT512OYT1CRR2
grape seed oilINACTIVE INGREDIENT930MLC8XGG2
mentholINACTIVE INGREDIENTL7T10EIP3A2
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KY2
olive oilINACTIVE INGREDIENT6UYK2W1W1E2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2
saccharinINACTIVE INGREDIENTFST467XS7D2
thymolINACTIVE INGREDIENT3J50XA376E2
vanillinINACTIVE INGREDIENTCHI530446X2

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-953910157-9539-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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 2 · 114 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
vanillinVANILLINCHI530446XPOWDER, FOR SUSPENSION / ORAL2 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET / SUBLINGUAL0.2 mgExact identifier — unii candidate
16 equally ranked IID candidates
saccharinSACCHARINFST467XS7DDROPS / ORAL20 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
olive oilOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
microcrystalline waxMICROCRYSTALLINE WAXXOF597Q3KYCAPSULE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
4 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
vanillinVANILLINCHI530446XTABLET / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
saccharinSACCHARINFST467XS7DGRANULE, FOR SOLUTION / ORAL16 mgExact identifier — unii candidate
16 equally ranked IID candidates
vanillinVANILLINCHI530446XTABLET, COATED / ORAL65.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
vanillinVANILLINCHI530446XOINTMENT / TOPICALNAExact identifier — unii candidate
15 equally ranked IID candidates
olive oilOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
mentholMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
vanillinVANILLINCHI530446XTABLET, CHEWABLE / ORAL2.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
vanillinVANILLINCHI530446XLIQUID / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
16 equally ranked IID candidates
saccharinSACCHARINFST467XS7DELIXIR / ORAL2 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
vanillinVANILLINCHI530446XTABLET, EXTENDED RELEASE / ORAL3.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
saccharinSACCHARINFST467XS7DAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
olive oilOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
camphor (synthetic)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
microcrystalline waxMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
vanillinVANILLINCHI530446XTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
microcrystalline waxMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
olive oilOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
thymolTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET / ORAL4 mgExact identifier — unii candidate
4 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
saccharinSACCHARINFST467XS7DAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
microcrystalline waxMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
mentholMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
candelilla waxCANDELILLA WAXWL0328HX19TABLET, FILM COATED / ORAL0.8 mgExact identifier — unii candidate
4 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
vanillinVANILLINCHI530446XSUSPENSION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
mentholMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
saccharinSACCHARINFST467XS7DTABLET / ORAL1.6 mgExact identifier — unii candidate
16 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
374e1e4e-e5c2-4089-a86c-a86ed39d67c9197a2d5b-cd4b-431e-940b-f76684db74512012-03-16WarningsExact identifier
spl id: 374e1e4e-e5c2-4089-a86c-a86ed39d67c9
spl set id: 197a2d5b-cd4b-431e-940b-f76684db7451

Reported adverse events (FAERS/openFDA)#

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