FDA.reportPublic FDA data

OXY STEM M SERUM

Manufacturer
ULAB | U-LAB Switzerland AG
Effective date
2017-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:19

Label at a glance#

ProductOXY STEM M SERUM
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: DIMETHICONE 2.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: AQUA (WATER), Propylene Glycol, Glycerin, PEG-7 Glyceryl Cocoate, Water (aqua), Pentylene Glycol, Tocopheryl Acetate, Hydrolyzed Pea, PEG-40 Hydrogenated Castor Oil, Trideceth-9, Glycerin, Retinyl Palmitate, Carbomer, Triethanolamine, Fructose, Urea, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Glycoproteins, Glutamic Acid, Valine, Threonine, Maltose, Sodium PCA, Sodium Chloride, Sodium Lactate, Trehalose, Allantoin, Sodium Hyaluronate, Glucose

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anti-fatigue and lifting Serum

WARNINGS

WARNINGS SECTION

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

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

Indications & Usage: Apply morning and night

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Apply morning and night on clean face and neck prior to moisturizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244642dimethicone 2 % Topical CreamPSN1
244642dimethicone 20 MG/ML Topical CreamSCD1
244642dimethicone 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71276-070-022020-01-31C16284748780-19d75b9d1-0597-f424-e053-dadaa90a57ce4dc5c4da-827b-4675-b2f0-64b712a55417

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71276-070-01OXY STEM M SERUM50 mL in 1 BOTTLE, PUMPCREAM501
71276-070-02OXY STEM M SERUM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71276-070OXY STEM M SERUM (DIMETHICONE) CREAM [ULAB]1Legacy NDC, 2 package rows20170322_4dc5c4da-827b-4675-b2f0-64b712a55417.zip

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
71276-07071276-070-01, 71276-070-02

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
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT

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
f89a76b1-1135-45d8-a905-6ec5fe3f86594dc5c4da-827b-4675-b2f0-64b712a554172017-03-22WarningsExact identifier
spl id: f89a76b1-1135-45d8-a905-6ec5fe3f8659
spl set id: 4dc5c4da-827b-4675-b2f0-64b712a55417

Reported adverse events (FAERS/openFDA)#

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