FDA.reportPublic FDA data

Luxury Cell Performance

Manufacturer
Pharmicell Co., Ltd.
Effective date
2014-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:16

Label at a glance#

ProductLuxury Cell Performance
Active ingredientDIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient : DIMETHICONE 1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, DIPROPYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, NEOPENTYL GLYCOL DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ETHYLHEXANOATE, BETAINE, BUTYROSPERMUM PARKII(SHEA BUTTER),
STEARIC ACID, GLYCERYL STEARATE SE, PEG-40 STEARATE, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEESWAX, POLYGONUM MULTIFLORUM ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 1,2-HEXANEDIOL, CARBOMER, PHENOXYETHANOL, CETEARETH-20, HYDROGENATED LECITHIN, GLYCERYL STEARATE, SORBITAN STEARATE, XANTHAN GUM, POTASSIUM HYDROXIDE, DIPOTASSIUM GLYCYRRHIZATE, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, CERAMIDE 3, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTUS GLOBULUS LEAF OIL, GERANIUM MACULATUM OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA PIPERITA (PEPPERMINT)OIL, ADENOSINE, SODIUM HYALURONATE

PURPOSE

OTC - PURPOSE SECTION

Purpose : Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings : Harmful if swallowed. Avoid contact with the eyes. Keep out of reach of children. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

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

Indication and usage : At the last step of skin care, take the cream with a size of pea using a spatula, and spread it evenly over the face and neck, and press the face lightly with both hands.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200010dimethicone 1 % Topical CreamPSN1
200010dimethicone 10 MG/ML Topical CreamSCD1
200010dimethicone 1 % 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
60949-160-012019-11-27C16284748780-19855e2a2-3abf-60a7-e053-dbdaa90a05bdee4c8347-8ffd-4ee9-8570-5e0ec2b94723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60949-160-01Luxury Cell Performance50 g in 1 CARTONCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60949-160LUXURY CELL PERFORMANCE (DIMETHICONE) CREAM [PHARMICELL CO., LTD.]1Legacy NDC, 1 package rows20140922_ee4c8347-8ffd-4ee9-8570-5e0ec2b94723.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
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
60949-16060949-160-01

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
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 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
cd227d1c-f94e-4ba0-ab36-ed2dd23f8881ee4c8347-8ffd-4ee9-8570-5e0ec2b947232014-09-22WarningsExact identifier
spl id: cd227d1c-f94e-4ba0-ab36-ed2dd23f8881
spl set id: ee4c8347-8ffd-4ee9-8570-5e0ec2b94723

Reported adverse events (FAERS/openFDA)#

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