FDA.reportPublic FDA data

Artistry Exact Fit Longwearing Foundation Shade Brule

Manufacturer
Amway Corp
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:11

Label at a glance#

ProductArtistry Exact Fit Longwearing Foundation Shade Brule L4W1
Active ingredientTITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

For suncreen use Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating or washing Reapply at least every 2 hours Spending time in the sun increases your risk of skin cancer and early skin aging. Sun Protection Measures. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time i...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.025% (W/W P/P)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on broken or damaged skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For suncreen use

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating or washing
  • Reapply at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. Sun Protection Measures.
  • To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, CYCLOPENTASILOXANE, TRIMETHYLSILOXYSILICATE, GLYCERIN, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYPHENYL DIMETHICONE, TALC, SILICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYSILICONE-11, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, ALUMINA, POLYSORBATE-20, SODIUM CHLORIDE, SODIUM CITRATE, STEAROYL GLUTAMIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, TOCOPHERYL ACETATE, PROPYLPARABEN, ETHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, PEARL POWDER, LAURETH-12, LECITHIN, CERAMIDE NP, BETA-SITOSTEROL, SODIUM HYALURONATE, GLUCOSAMINE HCL, UREA, YEAST EXTRACT, ALGAE EXTRACT, TOCOPHEROL CITRIC ACID, SODIUM HYDROXIDE MAY CONTAIN / PEUT CONTIENIR: IRON OXIDES (CI 77491, 77492, 77499), BISMUTH OXYCHLORIDE (CI 77163), TITANIUM DIOXIDE (CI 77891).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0Shade0Shade0

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50390-200-30Artistry Exact Fit Longwearing Foundation Shade Brule L4W130 mL in 1 BOTTLE, PLASTICCREAM302
50390-200-30Artistry Exact Fit Longwearing Foundation Shade Brule L4W11 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50390-200ARTISTRY EXACT FIT LONGWEARING FOUNDATION SHADE BRULE L4W1 (TITANIUM DIOXIDE) CREAM [AMWAY CORP]2Current NDC, Legacy NDC, 2 package rows20231022_19d08a86-5a60-4633-8a3c-96bab9a17fcc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50390-20050390-200-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
TALC7SEV7J4R1UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM OXIDELMI26O6933IACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
STEAROYL GLUTAMIC ACID4R4O71786GIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
ETHYLPARABEN14255EXE39IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PEARL (HYRIOPSIS CUMINGII)A75L5FZ40UIACT
LAURETH-12OAH19558U1IACT
CERAMIDE NP4370DF050BIACT
.BETA.-SITOSTEROLS347WMO6M4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
UREA8W8T17847WIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1TITANIUM DIOXIDEAmway Corp19d08a86-5a60-4633-8a3c-96bab9a17fcc2023-10-21WarningsExact identifier
ndc (package): 50390-200-30
ndc (product): 50390-200
ndc11 (package): 50390020030
spl id: 08383916-d50e-c45c-e063-6394a90a9247
spl set id: 19d08a86-5a60-4633-8a3c-96bab9a17fcc

Reported adverse events (FAERS/openFDA)#

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