ARTISTRY EXACT FIT LONGWEARING FOUNDATION SPF 15 BROAD SPECTRUM SUNSCREEN- titanium dioxide cream

Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Amway Corp, Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxe 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
■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  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. MAY CONTAIN / PEUT CONTIENIR: IRON OXIDES (CI 77491, 77492, 77499), BISMUTH OXYCHLORIDE (CI 77163), TITANIUM DIOXIDE (CI 77891).

Product Labels

INGREDIENTS AND APPEARANCE

ARTISTRY EXACT FIT LONGWEARING FOUNDATION SPF 15 BROAD SPECTRUM SUNSCREEN 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-003
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.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 3 (UNII: 4370DF050B)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
UREA (UNII: 8W8T17847W)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-003-30	1 in 1 CARTON	05/01/2015
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2015

Labeler - Amway Corp (083416854)

Establishment
Name	Address	ID/FEI	Business Operations
Access Business Group LLC		839830713	manufacture(50390-003)