FDA.reportPublic FDA data

Softlips

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:06

Label at a glance#

ProductSoftlips Tropical Coconut Peach Passion
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetatate [vitamin E]

Questions?

OTC - QUESTIONS SECTION

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

softlips.com

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Softlips Coconut Peach
Softlips Coconut Peach

Package/Label 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
10742-7005-12023-02-07C16284748780-1f386c649-acf6-0266-e053-dadaa90a7c1aDrug Facts
10742-7005-12023-01-30C16284748780-1f386c649-acf6-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-7005-1SoftlipsTropical Coconut Peach Passion2 in 1 BLISTER PACKSTICK23
10742-7005-1SoftlipsTropical Coconut Peach Passion2 g in 1 TUBESTICK23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-7005SOFTLIPS TROPICAL COCONUT PEACH PASSION (DIMETHICONE) STICK [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_11f619e7-4a58-45e4-8f4a-fe358832ab64.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-700510742-7005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
ETHYLHEXYL PALMITATE2865993309IACT
SQUALANEGW89575KF9IACT
OCTYLDODECANOL461N1O614YIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
CASTOR OILD5340Y2I9GIACT
MYRISTYL LACTATE1D822OC34XIACT
CETYL ALCOHOL936JST6JCNIACT
MYRISTYL LAURATE58U0NZN2BTIACT
MYRISTYL ALCOHOLV42034O9PUIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
LEVOMENTHOLBZ1R15MTK7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OACTIB

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
Softlips Tropical Coconut Peach PassionDIMETHICONEThe Mentholatum Company11f619e7-4a58-45e4-8f4a-fe358832ab642024-12-17WarningsExact identifier
ndc (package): 10742-7005-1
ndc (product): 10742-7005
ndc11 (package): 10742700501
spl id: 2978c0ed-ccf4-dcf5-e063-6394a90afb05
spl set id: 11f619e7-4a58-45e4-8f4a-fe358832ab64

Reported adverse events (FAERS/openFDA)#

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