FDA.reportPublic FDA data

3CE LIP COLOR 401 SCANDAL

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

Label at a glance#

Product3CE LIP COLOR 401 SCANDAL
Active ingredientTitanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Titanium Dioxide 1.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Triethylhexanoin, Polyglyceryl-2 Triisostearate, Trimethylolpropane Tricaprylate/Tricaprate, Isononyl Isononanoate, Mica (CI 77019), Diisostearyl Malate, Diglyceryl Sebacate/Isopalmitate, Silica, Ceresin, Ozokerite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Pentaerythrityl Tetraisostearate, Red 6 (CI 15850), Red 28 Lake (CI 45410), VP/Hexadecene Copolymer, Microcrystalline Wax, Sorbitan Isostearate, Silica Silylate, Polyethylene, Synthetic Wax, Silica Dimethyl Silylate, Polyglyceryl-2 Diisostearate, Methicone, Ethylene/Propylene Copolymer, Cholesteryl Macadamiate, Methylparaben, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Water, Butylene Glycol, Diamond powder, Amethyst Powder, Pearl Powder, Tourmaline

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

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

DESCRIPTION

DESCRIPTION SECTION

INSTRUCTIONS: A rich color lipstick that moistly adheres to lips.

Directions: Twist to dispense makeup and apply evenly to lips

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-069-022020-01-31C16284748780-19d75b9d0-0a06-f424-e053-dadaa90a57cedbca48c9-28c9-4d51-a6d1-f6368890140c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-069-013CE LIP COLOR 401 SCANDAL3.5 g in 1 BOTTLELIPSTICK3.51
60764-069-023CE LIP COLOR 401 SCANDAL1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-0693CE LIP COLOR 401 SCANDAL (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]1Legacy NDC, 2 package rows20161005_dbca48c9-28c9-4d51-a6d1-f6368890140c.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
60764-06960764-069-01, 60764-069-02

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
Triethylhexanoin7K3W1BIU6KIACT
Isononyl IsononanoateS4V5BS6GCXIACT

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
e8a91fd2-5b30-4e48-af89-1de2871cb9afdbca48c9-28c9-4d51-a6d1-f6368890140c2016-10-05WarningsExact identifier
spl id: e8a91fd2-5b30-4e48-af89-1de2871cb9af
spl set id: dbca48c9-28c9-4d51-a6d1-f6368890140c

Reported adverse events (FAERS/openFDA)#

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