FDA.reportPublic FDA data

3CE LIP COLOR 805 R 19

Manufacturer
Nanda Co., Ltd | Cosmax, Inc.
Effective date
2016-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:19

Label at a glance#

Product3CE LIP COLOR 805 R 19
Active ingredientTitanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Titanium Dioxide 3.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Diisostearyl Malate, Triethylhexanoin, EthylhexylHydroxystearate, IsononylIsononanoate, Silica, Microcrystalline Wax, Ceresin, Ozokerite, DiglycerylSebacate/Isopalmitate, Octyldodecanol, Alumina, Red 28 Lake (CI 45410), Polyglyceryl-2 Triisostearate, Dicalcium Phosphate, VP/Hexadecene Copolymer, SorbitanIsostearate, Euphorbia Cerifera (Candelilla) Wax, Mica (CI 77019), Polyglyceryl-2 Diisostearate, Polyethylene, Red 7 (CI 15850:1), PentaerythritylTetraisostearate, Silica Dimethyl Silylate, Yellow 6 Lake (CI 15985), Tocopheryl Acetate, Blue 1 Lake (CI 42090), MangiferaIndica (Mango) Seed Butter, ButyrospermumParkii (Shea) Butter, Diamond powder, Water, Butylene Glycol, Amethyst Powder, Pearl Powder, Tourmaline, Methylparaben

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
60764-056-022020-01-31C16284748780-19d75b9d0-61d2-f424-e053-dadaa90a57ce5a57b0bb-7094-4893-8ddb-3bc677575d23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-056-013CE LIP COLOR 805 R 193.5 g in 1 BOTTLELIPSTICK3.51
60764-056-023CE LIP COLOR 805 R 191 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-0563CE LIP COLOR 805 R 19 (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]1Legacy NDC, 2 package rows20161004_5a57b0bb-7094-4893-8ddb-3bc677575d23.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
60764-05660764-056-01, 60764-056-02

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
Diisostearyl MalateQBS8A3XZGQIACT
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
1602fb36-9cfd-46cd-8ed9-c075c415a0e55a57b0bb-7094-4893-8ddb-3bc677575d232016-10-04WarningsExact identifier
spl id: 1602fb36-9cfd-46cd-8ed9-c075c415a0e5
spl set id: 5a57b0bb-7094-4893-8ddb-3bc677575d23

Reported adverse events (FAERS/openFDA)#

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