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 Pearl Plus Vanilla
Active ingredientOCTINOXATE, OCTISALATE, DIMETHICONE, OXYBENZONE
Label structure20 sections

Indications and uses

helps prevent sunburn

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

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Softlips Pearl

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Octinoxate – Sunscreen

Octisalate - Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Agent 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

OTC - WHEN USING SECTION

this product 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

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.

Dosage and Administration

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Softlips.com

SPL UNCLASSIFIED SECTION

Softlips Vanilla

Drug Facts

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

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

WARNINGS SECTION

Skin Cancer/Skin Agent 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

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.

Dosage and Administration

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Softlips.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front Blistercard
Front Blistercard

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back Blistercard
Back Blistercard

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
10742-7011-12023-02-07C16284748780-1f386c649-e10d-0266-e053-dadaa90a7c1aSOFTLIPS PEARL PLUS VANILLA
10742-7011-12023-01-30C16284748780-1f386c649-e10d-0266-e053-dadaa90a7c1aSOFTLIPS PEARL PLUS VANILLA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-7011-1SoftlipsPearl Plus Vanilla1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-7011SOFTLIPS PEARL PLUS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) KIT [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 1 package rows20241219_107bcaa9-4347-4979-be44-35183a9ee67e.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-701110742-7011-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN OILOVV5IIJ58FIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
CERESINQ1LS2UJO3AIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
MINERAL OILT5L8T28FGPIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
OLEYL ALCOHOL172F2WN8DVIACT
CARNAUBA WAXR12CBM0EIZIACT
CASTOR OILD5340Y2I9GIACT
CETYL LACTATEA7EVH2RK4OIACT
PARAFFINI9O0E3H2ZEIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MAGNESIUM STEARATE70097M6I30IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
CARMINIC ACIDCID8Z8N95NIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
CERESINQ1LS2UJO3AIACT
SQUALANEGW89575KF9IACT
ETHYLHEXYL PALMITATE2865993309IACT
PETROLATUM4T6H12BN9UIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
MYRISTYL LACTATE1D822OC34XIACT
CETYL ALCOHOL936JST6JCNIACT
MYRISTYL LAURATE58U0NZN2BTIACT
MYRISTYL ALCOHOLV42034O9PUIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
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 Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
ndc (package): 10742-7011-1
ndc (product): 10742-7011
ndc11 (package): 10742701101
spl id: 2978d002-ed43-0525-e063-6394a90a982f
spl set id: 107bcaa9-4347-4979-be44-35183a9ee67e

Reported adverse events (FAERS/openFDA)#

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