ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN MEDIUM- ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium by

Drug Labeling and Warnings

Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium 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

Ensulizole 2.0% (W/W P/P)
Octinoxate 5.5% (W/W P/P)
Oxybenzone 0.5% (WW P/P)
Titanium Dioxide 0.84% (W/W P/P)
Zinc Oxide 9.8% (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.

Keep out of reach of children.

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

Other Information

■ Protect this product from excessive heat and direct sun

Inactive Ingredients

WATER/EAU/AQUA, DIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TALC, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE, TRIETHANOLAMINE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, PEG/PPG-18/18 DIMETHICONE, ALUMINA, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, FRAGRANCE/PARFUM, SILICA, PROPYLPARABEN, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, MALTODEXTRIN, ETHYLPARABEN,, IODOPROPYNYL BUTYLCARBAMATE, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, LECITHIN, SOPHORA JAPONICA FLOWER POWDER, GERANIUM ROBERTIANUM EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, LACTOBACILLUS/ACEROLA CHERRY FERMENT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, TOCOPHERYL ACETATE, CERAMIDE-3, BETA-SITOSTEROL, TETRAHEXYLDECYL ASCORBATE, MAY CONTAIN/PEUT CONTEINIR: IRON OXIDES (CI 77491, CI 77492, CI 77499), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891).

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN MEDIUM 
ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	98 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TALC (UNII: 7SEV7J4R1U)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
TROLAMINE (UNII: 9O3K93S3TK)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRISILOXANE (UNII: 9G1ZW13R0G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLPARABEN (UNII: 14255EXE39)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-002-30	1 in 1 CARTON	05/01/2015
1		30 mL in 1 TUBE; 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(50390-002)