FDA.reportPublic FDA data

UNIWELL NATURAL ESSENCE

Manufacturer
uniwell LTD | Cosmecca Korea Co., Ltd.
Effective date
2017-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:50:06

Label at a glance#

ProductUNIWELL NATURAL ESSENCE
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DIMETHICONE 1.875%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.


DOSAGE & ADMINISTRATION SECTION

Apply as needed.

WARNINGS SECTION

For external use only.
Do not use on deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if condition worsen, symptoms last more than 7 days or clean up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Arginine, Carbomer, Propanediol, Polyacrylate-13, Hydroxyacetophenone, Polyisobutene, Citrus Aurantium Dulcis (Orange) Oil, Allantoin, Dipotassium Glycyrrhizate, Adenosine, Ethylhexylglycerin, Polysorbate 20, Phenoxyethanol, Theobroma Cacao (Cocoa) Extract, Sorbitan Isostearate, Disodium EDTA, Beta-Glucan, Dextrin, Ecklonia cava Extract, Glycine Soja (Soybean) Sprout Extract, Triticum Vulgare (Wheat) Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Camellia Oleifera Leaf Extract, Magnolia Liliflora Flower Extract, Eugenia Caryophyllus (Clove) Bud Extract, Sophora Japonica Flower Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Alcohol, Phenoxyethanol, Sodium Hyaluronate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71502-002-022020-01-31C16284748780-19d75b9d0-8c7d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71502-002-01UNIWELL NATURAL ESSENCE50 mL in 1 CONTAINEREMULSION502
71502-002-02UNIWELL NATURAL ESSENCE1 in 1 PACKAGEEMULSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71502-002UNIWELL NATURAL ESSENCE (DIMETHICONE) EMULSION [UNIWELL LTD]2Legacy NDC, 2 package rows20170613_5d4d3fc1-1172-4193-bac2-ff97d8132488.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71502-00271502-002-01, 71502-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
GlycerinPDC6A3C0OXIACT
1,2-HexanediolTR046Y3K1GIACT
NIACINAMIDE25X51I8RD4IACT
SqualaneGW89575KF9IACT
Arginine94ZLA3W45FIACT
Propanediol5965N8W85TIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
2-HYDROXYACETOPHENONEDQ1N9R01IAIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ORANGE OILAKN3KSD11BIACT
Allantoin344S277G0ZIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
AdenosineK72T3FS567IACT
Ethylhexylglycerin147D247K3PIACT
Polysorbate 207T1F30V5YHIACT
COCOAD9108TZ9KGIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ECKLONIA CAVAUXX2N5V39PIACT
SOYBEANL7HT8F1ZODIACT
WHEAT SPROUT3K32950CI0IACT
BROCCOLI SPROUT128UH9LOAEIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
MAGNOLIA LILIIFLORA FLOWERSVM28292LHIACT
CLOVEK48IKT5321IACT
STYPHNOLOBIUM JAPONICUM FLOWER644C3CSB6EIACT
LAVENDER OILZBP1YXW0H8IACT
LEMON OILI9GRO824LLIACT
ALCOHOL3K9958V90MIACT
PhenoxyethanolHIE492ZZ3TIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
cfdcb8e6-9a69-4480-8587-28ad3b3ce5a85d4d3fc1-1172-4193-bac2-ff97d81324882017-06-12WarningsExact identifier
spl id: cfdcb8e6-9a69-4480-8587-28ad3b3ce5a8
spl set id: 5d4d3fc1-1172-4193-bac2-ff97d8132488

Reported adverse events (FAERS/openFDA)#

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