FDA.reportPublic FDA data

3CE SKIN TONE CONTROL PRIMER PURE VIOLET

Manufacturer
Nanda Co., Ltd | Cosmax, Inc.
Effective date
2016-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:35

Label at a glance#

Product3CE SKIN TONE CONTROL PRIMER PURE VIOLET
Active ingredientDimethicone
Label structure8 sections

Dosage and administration

Directions: Apply basic makeup such as moisturizer and sunscreen. Then, place primer on face by using a makeup brush or sponge. Pat on lightly for a smooth finish.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dimethicone 3.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Butylene Glycol, Triethylhexanoin, Titanium Dioxide (CI 77891), Phenyl Trimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclopentasiloxane, Silica, Mica (CI 77019), Cetyl Dimethicone, Cetearyl Alcohol, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, PEG-2 Stearate, PEG-100 Stearate, Dimethicone Crosspolymer, Sodium Polyacrylate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Laureth-4, Laureth-23, Ethylhexylglycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Ultramarines (CI 77007), Xanthan Gum, Polysorbate 80, Iron Oxides (CI 77499)

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

CAUTION

WARNINGS SECTION

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep it out of children's reach

INSTRUCTIONS

INDICATIONS & USAGE SECTION

INSTRUCTIONS: This primer helps foundation adhere better on skin and lengthens the longevity of the foundation. Moreover, it gives a brighter skin tone so that you can have a better finish

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply basic makeup such as moisturizer and sunscreen. Then, place primer on face by using a makeup brush or sponge. Pat on lightly for a smooth finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1309346dimethicone 3.1 % Topical CreamPSN1
1309346dimethicone 31 MG/ML Topical CreamSCD1
1309346dimethicone 3.1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809348113135GTIN-13: 8809348113135
EAN-13: 8809348113135
GTIN storage (14 digits): 08809348113135		3ce skin tone control primer pure violet carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-128-022020-01-31C16284748780-19d75b9d0-e569-f424-e053-dadaa90a57ce4ee63d08-8afd-4df3-960c-3d9a4ef26609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-128-013CE SKIN TONE CONTROL PRIMER PURE VIOLET30 mL in 1 TUBECREAM301
60764-128-023CE SKIN TONE CONTROL PRIMER PURE VIOLET1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-1283CE SKIN TONE CONTROL PRIMER PURE VIOLET (DIMETHICONE) CREAM [NANDA CO., LTD]1Legacy NDC, 2 package rows20161014_4ee63d08-8afd-4df3-960c-3d9a4ef26609.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
60764-12860764-128-01, 60764-128-02

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
Butylene Glycol3XUS85K0RAIACT

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
9f2eb7a8-4e2f-474f-bb50-7c4c41997f7a4ee63d08-8afd-4df3-960c-3d9a4ef266092016-10-14WarningsExact identifier
spl id: 9f2eb7a8-4e2f-474f-bb50-7c4c41997f7a
spl set id: 4ee63d08-8afd-4df3-960c-3d9a4ef26609

Reported adverse events (FAERS/openFDA)#

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