OXY STEM M

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
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: DIMETHICONE 14.12%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Aqua (WATER), Glycerin, Glyceryl Stearate SE, Propylene Glycol, Water (aqua), Cetyl Alcohol, Hydrolyzed Pea, Pentylene Glycol, Glycerin, Carbomer, Triethanolamine, Fructose, Urea, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Glycoproteins, Glutamic Acid, Maltose, Sodium PCA, Sodium Chloride, Sodium Lactate, Trehalose, Allantoin, Valine, Threonine, Sodium Hyaluronate, Glucose

PURPOSE

OTC - PURPOSE SECTION

Purpose: Long-lasting moisturizing and skin smoothing

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 after Oxy-Stem M Serum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

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
71276-080-022020-01-31C16284748780-19d75b9cf-fe1e-f424-e053-dadaa90a57ce31715101-fac0-43b6-b86b-5c8082c73c28

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71276-080-01OXY STEM M50 mL in 1 BOTTLE, PUMPCREAM501
71276-080-02OXY STEM M1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71276-080OXY STEM M (DIMETHICONE) CREAM [ULAB]1Legacy NDC, 2 package rows20170322_31715101-fac0-43b6-b86b-5c8082c73c28.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
71276-08071276-080-01, 71276-080-02

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
GlycerinPDC6A3C0OXIACT

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
8712c4a5-f1fb-46c7-aa29-44bd1a8d0ab131715101-fac0-43b6-b86b-5c8082c73c282017-03-22WarningsExact identifier
spl id: 8712c4a5-f1fb-46c7-aa29-44bd1a8d0ab1
spl set id: 31715101-fac0-43b6-b86b-5c8082c73c28

Reported adverse events (FAERS/openFDA)#

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