ARTISTRY EXACT FIT LONGWEARING FOUNDATION SHADE SOLEIL L3W1- titanium dioxide cream

Artistry Exact Fit Longwearing Foundation Shade Soleil by

Drug Labeling and Warnings

Artistry Exact Fit Longwearing Foundation Shade Soleil by is a Otc medication manufactured, distributed, or labeled by Amway Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

Do not use

on broken or damaged skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

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

• Protect this product from excessive heat and direct sun

Inactive ingredients

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:

INGREDIENTS AND APPEARANCE

ARTISTRY EXACT FIT LONGWEARING FOUNDATION SHADE SOLEIL   L3W1
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ETHYLPARABEN (UNII: 14255EXE39)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
LAURETH-12 (UNII: OAH19558U1)
CERAMIDE NP (UNII: 4370DF050B)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
UREA (UNII: 8W8T17847W)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-208-30	1 in 1 CARTON	05/01/2015
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2015

Labeler - Amway Corp (083416854)