FDA.reportPublic FDA data

Medicated Peppermint Lip Balm

Manufacturer
Blistex Inc
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:02

Label at a glance#

ProductMedicated Peppermint Lip Balm
Active ingredientDIMETHICONE, UNSPECIFIED, 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
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.

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, cetyl alcohol, cetyl palmitate, euphorbia cerifera (candelilla) wax, flavors, isopropyl myristate, lanolin, lanolin oil, mentha piperita (peppermint) oil, menthol, mineral oil, ozokerite, paraffin, petrolatum, phenoxyethanol, polybutene, red 6 lake, saccharin, theobroma cacao (cocoa) seed butter

PRINCIPAL DISPLAY PANEL - 3 Stick Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistex®

LIMITED
EDITION

DERMATOLOGIST RECOMMENDED

MEDICATED PEPPERMINT BALM
LIP PROTECTANT/SUNSCREEN

SPF 15

3 Sticks
Net Wt. 0.15 oz. (4.25 g) Ea.

3 Pack

PRINCIPAL DISPLAY PANEL - 3 Stick Carton
PRINCIPAL DISPLAY PANEL - 3 Stick 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
10157-4104-3Medicated Peppermint Lip Balm4.25 g in 1 CYLINDERSTICK4.251
10157-4104-3Medicated Peppermint Lip Balm3 in 1 CARTONSTICK31
10157-4104-4Medicated Peppermint Lip Balm4.25 g in 1 CYLINDERSTICK4.251
10157-4104-4Medicated Peppermint Lip Balm4 in 1 CARTONSTICK41

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-410410157-4104-3, 10157-4104-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
CANDELILLA WAXWL0328HX19IACT
LANOLIN OILOVV5IIJ58FIACT
YELLOW WAX2ZA36H0S2VIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
CETYL PALMITATE5ZA2S6B08XIACT
CETYL ALCOHOL936JST6JCNIACT
PARAFFINI9O0E3H2ZEIACT
PEPPERMINT OILAV092KU4JHIACT
COCOA BUTTER512OYT1CRRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SACCHARINFST467XS7DIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
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
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
ndc (package): 10157-4104-3
ndc (package): 10157-4104-4
ndc (product): 10157-4104
ndc11 (package): 10157410403
ndc11 (package): 10157410404
spl id: 1880a0de-8d54-4b06-a8d0-cf63de96b57f
spl set id: 5d48a6fa-ddce-47c3-9b09-1f3abb695017

Reported adverse events (FAERS/openFDA)#

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