FDA.reportPublic FDA data

Mentholatum Medicated Lip Balm

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:14

Label at a glance#

ProductMentholatum Medicated Lip Balm Cherry
Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE
Label structure9 sections

Indications and uses

helps prevent sunburn temporarily protects chapped or cracked lips

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, flavor, lanolin, menthol, mineral oil, ozokerite, petrolatum

Questions?

OTC - QUESTIONS SECTION

Toll free 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mentholatum Medicated Lip Balm Cherry
Mentholatum Medicated Lip Balm Cherry

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8893-12023-02-07C16284748780-1f386c64a-255d-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Medicated Lip Balm Cherry
10742-8893-32023-02-07C16284748780-1f386c64a-255d-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Medicated Lip Balm Cherry
10742-8893-12023-01-30C16284748780-1f386c64a-255d-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Medicated Lip Balm Cherry
10742-8893-32023-01-30C16284748780-1f386c64a-255d-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Medicated Lip Balm Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8893-1Mentholatum Medicated Lip BalmCherry4.2 g in 1 TUBEOINTMENT4.24
10742-8893-1Mentholatum Medicated Lip BalmCherry1 in 1 BLISTER PACKOINTMENT14
10742-8893-3Mentholatum Medicated Lip BalmCherry4.2 g in 1 TUBEOINTMENT4.24
10742-8893-3Mentholatum Medicated Lip BalmCherry3 in 1 BLISTER PACKOINTMENT34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8893MENTHOLATUM MEDICATED LIP BALM CHERRY (DIMETHICONE, OCTINOXATE, OCTISALATE) OINTMENT [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 4 package rows20241219_6edb132d-bb67-4e6c-8e18-db0305073a71.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-889310742-8893-1, 10742-8893-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
LANOLIN7EV65EAW6HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
DIMETHICONE92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

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
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
ndc (package): 10742-8893-3
ndc (package): 10742-8893-1
ndc (product): 10742-8893
ndc11 (package): 10742889303
ndc11 (package): 10742889301
spl id: 2979e35f-a828-037a-e063-6394a90ac334
spl set id: 6edb132d-bb67-4e6c-8e18-db0305073a71

Reported adverse events (FAERS/openFDA)#

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