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 00:44:14

Label at a glance#

ProductSoftlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi
Active ingredientDIMETHICONE, OCTINOXATE, 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 Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 4%

Purpose

OTC - PURPOSE SECTION

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Oxybenzone – 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

Pineapple Coconut: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, ananas sativus (pineapple) fruit extract, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, cocos nucifera (coconut) extract, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Peach Mango: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, mangifera indica (mango) fruit extract, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, prunus persica (peach) fruit extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Strawberry Kiwi: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, actinidia chinesis (kiwi) fruit extract, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, fragaria vesca (strawberry) fruit extract, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Questions? 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 Oasis Drug Facts Front
Softlips Oasis Drug Facts Front

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Softlips Oasis Drug Facts Back
Softlips Oasis Drug Facts Back

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
10742-8744-12023-02-07C16284748780-1f386c649-a9a5-0266-e053-dadaa90a7c1aDrug Facts - Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi
10742-8744-12023-01-30C16284748780-1f386c649-a9a5-0266-e053-dadaa90a7c1aDrug Facts - Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8744-1SoftlipsOasis Pineapple Coconut, Peach Mango, Strawberry Kiwi4.5 g in 1 TUBESTICK4.53
10742-8744-1SoftlipsOasis Pineapple Coconut, Peach Mango, Strawberry Kiwi6 in 1 POUCHSTICK63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8744SOFTLIPS OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY KIWI (DIMETHICONE, OXYBENZONE, OCTINOXATE) STICK [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_7c8a4921-ae45-47fb-a64e-c72b1a386d0d.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
10742-874410742-8744-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
OCTYLDODECANOL461N1O614YIACT
ETHYLHEXYL PALMITATE2865993309IACT
POLYGLYCERYL-6 DISTEARATEZ35I17EQOPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
SODIUM CHLORIDE451W47IQ8XIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
KIWI FRUIT71ES77LGJCIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
PINEAPPLE2A88ZO081OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SAFFLOWER OIL65UEH262ISIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
COCONUT3RT3536DHYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALPINE STRAWBERRYCG6IX3GCMUIACT
HYALURONIC ACIDS270N0TRQYIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
MANGOI629I3NR86IACT
RACEMENTHOLYS08XHA860IACT
PHYMATOLITHON CALCAREUM6J1M3WA0ZKIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
PEACH3OKE88I3QGIACT
SILANETRIOLE52D0J3TS5IACT
SILYBUM MARIANUM SEED OILNYY23HEN06IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OACTIB
OCTINOXATE4Y5P7MUD51ACTIB
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 Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
ndc (package): 10742-8744-1
ndc (product): 10742-8744
ndc11 (package): 10742874401
spl id: 2979d713-f1e4-980f-e063-6394a90acd5b
spl set id: 7c8a4921-ae45-47fb-a64e-c72b1a386d0d

Reported adverse events (FAERS/openFDA)#

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