FDA.reportPublic FDA data

Leaders Insolution Coconut Gel Balancing Recovery Mask

Manufacturer
SANSUNG LIFE & SCIENCE CO., LTD.
Effective date
2015-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:15

Label at a glance#

ProductLeaders Insolution Coconut Gel Balancing Recovery Mask
Active ingredientWitch Hazel
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Butylene Glycol, Niacinamide ,Acer saccharum (Sugar Maple) extract, Portulaca Oleracea Extract, 1,2-Hexanediol , Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Betaine, Hydroxyethyl acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acetyl Dipeptide-3 Aminohexanoate , Achillea Millefolium Extract, Gentiana Lutea Root Extract, Lactobacillus, Leuconostoc Ferment Filtrate, Cocos Nucifera (Coconut) Fruit Extract, Caprylyl Glycol, Ethylhexylglycerin, Saururus Chinensis Extract, Melissa Officinalis Flower/Leaf/Stem Water, Anthemis Nobilis Flower Water, Calendula Officinalis Flower Water, Rosa Damascena Flower Water, Triticum Spelta Seed Water, Xanthan Gum, Ledum Palustre Extract, Ecklonia Cava Extract, Artemisia Capillaris Flower Extract, Houttuynia Cordata Extract, Water, Fragrance, Magnolia Obovata Bark Extract, Terminalia Chebula Fruit Extract, Caesalpinia Sappan Bark Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warning: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician. Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indication and usage: 1. Wipe skin with toner after washing face. Take out mask and remove paper attached to the mask. Attach mask to face according to face shape and remove protection film attached to the outer surface. 2. Take mask off after resting for 20~25 minutes lightly pat face to help essence absorb onto face.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration: 2-3 times a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cello packImage of cello pack

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codem.site.naver.com/097fsleaders insolution coconut balancing recovery mask cello pack.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69424-150-012020-01-31C16284748780-19d75b9d0-9e44-f424-e053-dadaa90a57ce8ef1b7e3-be29-4e80-882e-ff6b4897dc59

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69424-150-01Leaders Insolution Coconut Gel Balancing Recovery Mask30 mL in 1 CELLO PACKPATCH301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69424-150LEADERS INSOLUTION COCONUT GEL BALANCING RECOVERY MASK (WITCH HAZEL) PATCH [SANSUNG LIFE & SCIENCE CO., LTD.]1Legacy NDC, 1 package rows20150409_8ef1b7e3-be29-4e80-882e-ff6b4897dc59.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U341
WITCH HAZELACTIVE MOIETY101I4J0U341
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69424-15069424-150-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Witch Hazel101I4J0U34ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
2b18f1f5-c011-43e9-b1bf-22d62b7c79768ef1b7e3-be29-4e80-882e-ff6b4897dc592015-04-09WarningsExact identifier
spl id: 2b18f1f5-c011-43e9-b1bf-22d62b7c7976
spl set id: 8ef1b7e3-be29-4e80-882e-ff6b4897dc59

Reported adverse events (FAERS/openFDA)#

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