FDA.reportPublic FDA data

3CE DRAWING LIP PEN ENDEAR

Manufacturer
Nanda Co., Ltd
Effective date
2016-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:30

Label at a glance#

Product3CE DRAWING LIP PEN ENDEAR
Active ingredientTitanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Titanium Dioxide 21.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Mica, Hydrogenated Coco-Glycerides, Rhus Succedanea Fruit Wax, Stearic Acid, Yellow 6 Lake (CI 15985), Hydrogenated Castor Oil, Triethylhexanoin, Red 21 Lake (CI 45380), Acetylated Sucrose Distearate, Lanolin, Microcrystalline Wax, Red 7 Lake (CI 15850), Red 6 Lake (CI 15850), Butylparaben

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

CAUTION

WARNINGS SECTION

CAUTION: 1. If following problems occur upon using the product, stop use immediately; further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area shows above symptoms when exposed to direct sunlight. 2. Do not use on areas with skin conditions such as open wound, eczema, or any skin disease. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/low temperature or direct sunlight

DESCRIPTION

DESCRIPTION SECTION

INSTRUCTIONS: Pencil-type lipstick that glides on lips like a crayon.

Directions: Hold the pencil flat against the lip and apply by tracing your natural lip line, moving towards to fill in.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-104-022020-01-31C16284748780-19d75b9d0-6175-f424-e053-dadaa90a57ced6c9a15b-848d-4401-bc06-e3fa8b00acea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-104-013CE DRAWING LIP PEN ENDEAR1.1 g in 1 BOTTLELIPSTICK1.11
60764-104-023CE DRAWING LIP PEN ENDEAR1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-1043CE DRAWING LIP PEN ENDEAR (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]1Legacy NDC, 2 package rows20161012_d6c9a15b-848d-4401-bc06-e3fa8b00acea.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
60764-10460764-104-01, 60764-104-02

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
Titanium Dioxide15FIX9V2JPACTIB
MicaV8A1AW0880IACT
Triethylhexanoin7K3W1BIU6KIACT

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
78bf34be-0e6f-458a-8d66-fa9d1923efcdd6c9a15b-848d-4401-bc06-e3fa8b00acea2016-10-12WarningsExact identifier
spl id: 78bf34be-0e6f-458a-8d66-fa9d1923efcd
spl set id: d6c9a15b-848d-4401-bc06-e3fa8b00acea

Reported adverse events (FAERS/openFDA)#

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