Blistex

Manufacturer
Blistex Inc.
Effective date
2011-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:18

Label at a glance#

ProductBlistex Revive and Restore
Active ingredientDIMETHICONE, OCTINOXATE, OXYBENZONE, LANOLIN
Label structure13 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 children under six months of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts - Revive

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Dimethicone 1.0%(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

OTC - STOP USE SECTION

  • Stop use if skin rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally before sun exposure and as needed
  • children under six months of age:
    ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

acer saccharum (sugar maple) extract, aloe barbadensis leaf extract, beeswax, bis-diglyceryl polyacyladipate-2, butyrospermum parkii (shea butter), C10-30 cholesterol/lanosterol esters, caprylic/capric triglyceride, cholesteryl/behenyl/octyldodecyl lauroyl glutamate, citrus aurantium dulcis (orange) fruit extract, citrus medica limonum (lemon) extract, flavors, menthol, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, purified water, ricinus communis (castor) seed oil, saccharin, saccharum officinarum (sugar cane) extract, vaccinium myrtillus (bilberry) extract

SPL UNCLASSIFIED SECTION

Drug Facts - Restore

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.0%(w/w)

Purpose

OTC - PURPOSE SECTION

Skin protectant

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, bis-diglyceryl polyacyladipate-2, brassica campestris/aleurites fordi oil copolymer, C10-30 cholesterol/lanosterol esters, flavors, hydrogenated polyisobutene, jojoba esters, microcrystalline wax, myristyl myristate, octyldodecanol, phenoxyethanol, polybutene, saccharin, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-9848-2

Blistex®
REVIVE: LIP PROTECTANT/SUNSCREEN
RESTORE: LIP PROTECTANT

REVIVE &
RESTORE
™

REVIVE FORMULA
Leaves lips smooth, invigorated & protected
Shea butter, fruit extracts & SPF 15

RESTORE FORMULA
Makes lips soft, healthy & radiant
Phyto-nutrients & Vitamin E

JARS NEST
AND LOCK
TOGETHER

2 JARS
NET WT.
.20 oz.
(5.67g)ea.

NEW!

Principal Display Panel - Kit Package
Principal Display Panel - Kit Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041388002590GTIN-13: 0041388002590
EAN-13: 0041388002590
GTIN-12: 041388002590
UPC-A: 041388002590
GTIN storage (14 digits): 00041388002590
blistex-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10157-9848-22019-10-29C16284748780-1960f7f55-d259-8e05-e053-dbdaa90a074aBlistex ® REVIVE & RESTORE™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9848-2Blistex Revive and Restore1 in 1 PACKAGEKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9848BLISTEX (DIMETHICONE, OCTINOXATE, OXYBENZONE, AND LANOLIN) KIT [BLISTEX INC.]1Legacy NDC, 1 package rows20110824_38c455d3-7ec9-4493-9c06-b8aa018de7d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
LANOLINACTIVE INGREDIENT7EV65EAW6H1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
LANOLINACTIVE MOIETY7EV65EAW6H1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ACER SACCHARUM BARK/SAPINACTIVE INGREDIENTZ120VL0KAC1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BILBERRYINACTIVE INGREDIENT9P2U39H18W1
C10-30 CHOLESTEROL/LANOSTEROL ESTERSINACTIVE INGREDIENT137SL7IL0Y1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LEMONINACTIVE INGREDIENT24RS0A988O1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DY1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614Y1
ORANGEINACTIVE INGREDIENT5EVU04N5QU1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SACCHARININACTIVE INGREDIENTFST467XS7D1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SQUALANEINACTIVE INGREDIENTGW89575KF91
SUGARCANEINACTIVE INGREDIENT81H2R5AOH31
WATERINACTIVE INGREDIENT059QF0KO0R1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-984810157-9848-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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 · 109 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YFILM / TRANSDERMAL32.44 mgExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DDROPS / ORAL20 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YFILM, EXTENDED RELEASE / TRANSDERMAL253.4 mgExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DSYRUP / ORAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DTABLET, CHEWABLE / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DSUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DTABLET / ORAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
OCTYLDODECANOLOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii candidate
9 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DGRANULE, FOR SOLUTION / ORAL16 mgExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DTABLET / SUBLINGUAL0.2 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
SACCHARINSACCHARINFST467XS7DOINTMENT / TOPICAL0.5 %w/wExact 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
28606dc7-5e71-49ce-84ae-5cc90249c18a38c455d3-7ec9-4493-9c06-b8aa018de7d92011-08-24WarningsExact identifier
spl id: 28606dc7-5e71-49ce-84ae-5cc90249c18a
spl set id: 38c455d3-7ec9-4493-9c06-b8aa018de7d9

Reported adverse events (FAERS/openFDA)#

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