FDA.reportPublic FDA data

Seaweed Cleansing

Manufacturer
AMAROS CO., LTD.
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:08

Label at a glance#

ProductSeaweed Cleansing
Active ingredientMineral Oil
Label structure8 sections

Indications and uses

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3. Use it in the morning or evening.

Dosage and administration

Dosage and Administration: Apply an appropriate amount on face and rub it into skin by massage method. Wipe up face with warm water. Cleansing cream gently removes tough waterproof make up.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Mineral Oil 50%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Butylene Glycol, Polysorbate60, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Sorbitan Sesquioleate, Dimethicone, Caprylyl Glycol / Caprylhydroxamic Acid, Carbomer, Triethanolamine, Allantoin, Xanthan Gum, Simmondsia Chinensis(Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Algae Extract, Carica Papaya (Papaya) Leaf Extract, Ascorbic acid, Fragrance, CI 42053.

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist . 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.3. Use it in the morning or evening.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and Administration: Apply an appropriate amount on face and rub it into skin by massage method. Wipe up face with warm water. Cleansing cream gently removes tough waterproof make up.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809224530377GTIN-13: 8809224530377
EAN-13: 8809224530377
GTIN storage (14 digits): 08809224530377		seaweed cleansing carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60899-050-012022-01-28C16284748780-1d6a99b39-d1f1-a426-e053-dadaa90af4c2114ea742-6f0e-4179-a4d2-91d150518d5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60899-050-01Seaweed Cleansing150 mL in 1 CARTONLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60899-050SEAWEED CLEANSING (MINERAL OIL) LIQUID [AMAROS CO., LTD.]2Legacy NDC, 1 package rows20190411_114ea742-6f0e-4179-a4d2-91d150518d5d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
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
60899-05060899-050-01

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
Mineral OilT5L8T28FGPACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

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
a2562084-bf86-43c0-9da0-fba794724a10114ea742-6f0e-4179-a4d2-91d150518d5d2019-04-11WarningsExact identifier
spl id: a2562084-bf86-43c0-9da0-fba794724a10
spl set id: 114ea742-6f0e-4179-a4d2-91d150518d5d

Reported adverse events (FAERS/openFDA)#

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