FDA.reportPublic FDA data

Softlips Oasis Peach Mango

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:45:32

Label at a glance#

ProductSoftlips Oasis Peach Mango
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

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]

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Softlips Oasis Peach Mango
Softlips Oasis Peach Mango

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8743-12023-02-07C16284748780-1f386c64a-2e25-0266-e053-dadaa90a7c1aDrug Facts - Softlips Oasis Peach Mango
10742-8743-22023-02-07C16284748780-1f386c64a-2e25-0266-e053-dadaa90a7c1aDrug Facts - Softlips Oasis Peach Mango
10742-8743-12023-01-30C16284748780-1f386c64a-2e25-0266-e053-dadaa90a7c1aDrug Facts - Softlips Oasis Peach Mango
10742-8743-22023-01-30C16284748780-1f386c64a-2e25-0266-e053-dadaa90a7c1aDrug Facts - Softlips Oasis Peach Mango

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-874310742-8743-1, 10742-8743-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SAFFLOWER OIL65UEH262ISIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
4dd2d92b-9d1e-dbcb-e063-6294a90a539c176f9f0f-9fc2-44c8-b2a3-afb11259805a2026-03-25WarningsExact identifier
spl set id: 176f9f0f-9fc2-44c8-b2a3-afb11259805a

Reported adverse events (FAERS/openFDA)#

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