3CE CRE AMY LIP COLOR 10 ROLLER COASTER

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 22:47:36

Label at a glance#

Product3CE CRE AMY LIP COLOR 10 ROLLER COASTER
Active ingredientTitanium Dioxide
Label structure6 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Titanium Dioxide 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, PentaerythritylTetraisostearate, Diisostearyl Malate, Ozokerite, DiglycerylSebacate/Isopalmitate, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Ceresin, Microcrystalline Wax, Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, SorbitanIsostearate, Mica (CI 77019), Polyglyceryl-2 Triisostearate, Alumina, PhytosterylMacadamiate, Yellow 5 Lake (CI 19140), Red 7 (CI 15850:1), Red 6 (CI 15850), Yellow 10 Lake (CI 47005), Polyglyceryl-2 Diisostearate, GlycerylCaprylate, Caprylyl Glycol, Blue 1 Lake (CI 42090), ArganiaSpinosa Kernel Oil, TheobromaGrandiflorum Seed Butter

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: Intense moisturizing lip color lipstick that blends into your lips as soon as it is applied.

Directions: After applying a thin layer of lipstick, another layer of clear lip gloss will allow an additional transparency

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-119-022020-01-31C16284748780-19d75b9d0-619f-f424-e053-dadaa90a57ceb027d2af-5fbf-4663-8d75-fbc0ef4e0b21

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-119-013CE CRE AMY LIP COLOR 10 ROLLER COASTER4.5 g in 1 BOTTLELIPSTICK4.51
60764-119-023CE CRE AMY LIP COLOR 10 ROLLER COASTER1 in 1 CARTONLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-1193CE CRE AMY LIP COLOR 10 ROLLER COASTER (TITANIUM DIOXIDE) LIPSTICK [NANDA CO., LTD]1Legacy NDC, 2 package rows20161014_b027d2af-5fbf-4663-8d75-fbc0ef4e0b21.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
60764-11960764-119-01, 60764-119-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
6bffecb7-0a9d-4904-94ec-442f4414040ab027d2af-5fbf-4663-8d75-fbc0ef4e0b212016-10-14WarningsExact identifier
spl id: 6bffecb7-0a9d-4904-94ec-442f4414040a
spl set id: b027d2af-5fbf-4663-8d75-fbc0ef4e0b21

Reported adverse events (FAERS/openFDA)#

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