FDA.reportPublic FDA data

Softlips Salted Caramel, Candy Apple, Marshmallow Ghost

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 00:44:36

Label at a glance#

ProductSoftlips Salted Caramel, Candy Apple, Marshmallow Ghost
Active ingredientDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE
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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

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.

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 increased 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Softlips Lip Protectant/Sunscreen SPF 20: Salted Caramel, Candy Apple, Marshmallow Ghost
Softlips Lip Protectant/Sunscreen SPF 20: Salted Caramel, Candy Apple, Marshmallow Ghost

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
10742-7004-32023-02-07C16284748780-1f386c649-abb0-0266-e053-dadaa90a7c1aDrug Facts
10742-7004-32023-01-30C16284748780-1f386c649-abb0-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-7004-3Softlips Salted Caramel, Candy Apple, Marshmallow Ghost2 g in 1 TUBESTICK23
10742-7004-3Softlips Salted Caramel, Candy Apple, Marshmallow Ghost3 in 1 BLISTER PACKSTICK33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-7004SOFTLIPS SALTED CARAMEL, CANDY APPLE, MARSHMALLOW GHOST (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241220_42cf4623-0eb8-455a-b374-8e17e9336b92.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-700410742-7004-3

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
SQUALANEGW89575KF9IACT
ETHYLHEXYL PALMITATE2865993309IACT
PETROLATUM4T6H12BN9UIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
MYRISTYL LACTATE1D822OC34XIACT
CETYL ALCOHOL936JST6JCNIACT
MYRISTYL LAURATE58U0NZN2BTIACT
MYRISTYL ALCOHOLV42034O9PUIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB

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 Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
ndc (package): 10742-7004-3
ndc (product): 10742-7004
ndc11 (package): 10742700403
spl id: 2978b80f-8dbf-b26c-e063-6394a90af703
spl set id: 42cf4623-0eb8-455a-b374-8e17e9336b92

Reported adverse events (FAERS/openFDA)#

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