FDA.reportPublic FDA data

Blistex Medicated Lip Balm

Manufacturer
Blistex Inc
Effective date
2024-02-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:35

Label at a glance#

ProductBlistex Medicated Lip Balm
Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE
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
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistex®
LIP PROTECTANT/SUNSCREEN

MEDICATED
LIP BALM

Seals In Moisture
To Soothe & Prevent Dry Lips

Net Wt. 0.15 oz. (4.25 g)
SPF 15

Smooth
Easy-Gliding
Protection

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton
PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1119-1Blistex Medicated Lip Balm1 in 1 CARTONSTICK14
10157-1119-1Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-2Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-3Blistex Medicated Lip Balm3 in 1 CARTONSTICK34
10157-1119-3Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-4Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254
10157-1119-4Blistex Medicated Lip Balm4 in 1 CARTONSTICK44
10157-1119-5Blistex Medicated Lip Balm5 in 1 CARTONSTICK54
10157-1119-5Blistex Medicated Lip Balm4.25 g in 1 CYLINDERSTICK4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1119BLISTEX MEDICATED LIP BALM (DIMETHICONE, OCTINOXATE, AND OCTISALATE) STICK [BLISTEX INC]4Current NDC, Legacy NDC, 9 package rows20240214_8b4160ed-8889-4e3a-947f-a56c3324dbbe.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-111910157-1119-1, 10157-1119-3, 10157-1119-4, 10157-1119-5, 10157-1119-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
CERESINQ1LS2UJO3AIACT
CANDELILLA WAXWL0328HX19IACT
LANOLIN OILOVV5IIJ58FIACT
YELLOW WAX2ZA36H0S2VIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
CETYL PALMITATE5ZA2S6B08XIACT
CETYL ALCOHOL936JST6JCNIACT
PARAFFINI9O0E3H2ZEIACT
COCOA BUTTER512OYT1CRRIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHORF89Z8SAG3OIACT
METHYL SALICYLATELAV5U5022YIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C RED NO. 6481744AI4OIACT

Source Document#

Source XML

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
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
ndc (package): 10157-1119-4
ndc (package): 10157-1119-1
ndc (package): 10157-1119-3
ndc (package): 10157-1119-5
ndc (package): 10157-1119-2
ndc (product): 10157-1119
ndc11 (package): 10157111901
ndc11 (package): 10157111902
ndc11 (package): 10157111905
ndc11 (package): 10157111903
ndc11 (package): 10157111904
spl id: ea073bea-814d-4be1-b7cc-d71288674006
spl set id: 8b4160ed-8889-4e3a-947f-a56c3324dbbe

Reported adverse events (FAERS/openFDA)#

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