82235-304 THE PURE LOTUS Jeju Botanical Sun Cream

Manufacturer
THE LOTUS Co.,Ltd.
Effective date
2021-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:32

Label at a glance#

ProductTHE PURE LOTUS Jeju Botanical SunCream
Active ingredientOCTOCRYLENE, HOMOSALATE
Label structure11 sections

Indications and uses

helps prevent sunburn and decreases the risk of skin cancer and early skin aging caused by the sun.

Storage and handling

Store at room temperature away from direct sunlight.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalaste(10%)

Octocrylene(3%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

  • helps prevent sunburn and decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • symptoms last more than 7days or clear up and occur again within a few days

Do not use

OTC - DO NOT USE SECTION

  • Do not apply to wounds or damaged skin
  • In case of abnormal symptoms or side effects of red spots, swelling, or itching
  • Do not get into eyes.

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 immediately.

Direction

INDICATIONS & USAGE SECTION

For Sunscreen use;

  • Apply to your skin evenly and put on 3~4times per day

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature away from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Butylene Glycol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, 1,2-Hexanediol, Nelumbo Nucifera Leaf Extract, Glyceryl Stearate, C14-22 Alcohols, Oryza Sativa (Rice) Extract, Cetearyl Olivate, Arachidyl Alcohol, Citrus Unshiu Peel Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Nelumbo Nucifera Root Extract, Tromethamine, VP/Eicosene Copolymer, Sorbitan Olivate, Opuntia Coccinellifera Fruit Extract, Behenyl Alcohol, Sodium Stearoyl Glutamate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Caprylyl Glycol, Citrus Limon (Lemon) Peel Oil, C12-20 Alkyl Glucoside, Carbomer, Arachidyl Glucoside, Mallotus Japonicus Bark Extract, Xanthan Gum, Adenosine, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Glucose, Citrus Aurantifolia (Lime) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Oil, Limonene, Linalool, Citral.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82235-304-0182235-304-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82235-304-012023-01-30C16284748780-1f386c649-a465-0266-e053-dadaa90a7c1a82235-304 THE PURE LOTUS Jeju Botanical Sun Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82235-304-01THE PURE LOTUS Jeju Botanical SunCream50 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82235-304THE PURE LOTUS JEJU BOTANICAL SUNCREAM (HOMOSALATE, OCTOCRYLENE) CREAM [THE LOTUS CO.,LTD.]1Legacy NDC, 1 package rows20210929_cd09edbc-3e52-7588-e053-2995a90aafd6.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82235-30482235-304-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

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
cd09edbc-3e53-7588-e053-2995a90aafd6cd09edbc-3e52-7588-e053-2995a90aafd62021-09-28WarningsExact identifier
spl id: cd09edbc-3e53-7588-e053-2995a90aafd6
spl set id: cd09edbc-3e52-7588-e053-2995a90aafd6

Reported adverse events (FAERS/openFDA)#

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