ARTISTRY IDEAL RADIANCE UV PROTECT SPF 50 PLUS BROAD SPECTRUM SUNSCREEN- octinoxate, octisalate, zinc oxide, titanium dioxide cream

ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen by

Drug Labeling and Warnings

ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Amway Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARTISTRY IDEAL RADIANCE UV Protect SPF 50+ Broad Spectrum Sunscreen

Active Ingredients

Octinoxate 6.8% (W/W P/P)
Octisalate 4.5% (W/W P/P)
Zinc Oxide 12.66% (W/W P/P)
Titanium Dioxide 2.49% (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.

Other information

Protect this product from excessive heat and direct sun

Inactive ingredients

WATER/AQUA, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, ALCOHOL, DICAPRYLYL CARBONATE, DIMETHICONE, PEG-10 DIMETHICONE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, FRAGRANCE / PARFUM, CAPRYLYL GLYCOL, PHENOXYETHANOL, POLYGLYCERYL-6 POLYRICINOLEATE, GLYCERYL CAPRYLATE, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, MALTODEXTRIN, SODIUM HYALURONATE, GLYCERIN, JASMINUM OFFICINALE(JASMINE) FLOWER EXTRACT, LECITHIN, HYDROLYZED CONCHIOLIN PROTEIN, SOPHORA JAPONICA LEAF EXTRACT, GERANIUM ROBERTIANUM EXTRACT, LACTOBACILLUS/ACEROLA CHERRY FERMENT, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, GLYCERIN, BETA-SITOSTEROL, CERAMIDE 3, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE.

Directions

For sunscreen use

• Apply liberally 15 minutes before sun exposure
• Reapply: immediately after towel drying, 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

Package Labeling:

INGREDIENTS AND APPEARANCE

ARTISTRY IDEAL RADIANCE UV PROTECT SPF 50 PLUS BROAD SPECTRUM SUNSCREEN 
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	126.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYL METHACRYLATE (UNII: 196OC77688)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
BELLIS PERENNIS (UNII: 2HU33I03UY)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
STYPHNOLOBIUM JAPONICUM LEAF (UNII: E63W4N1K61)
GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL)
ACEROLA (UNII: XDD2WEC9L5)
OENOTHERA BIENNIS SEED (UNII: 634OA3ULTM)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CERAMIDE 3 (UNII: 4370DF050B)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-108-30	1 in 1 CARTON	09/11/2013
1		30 mL in 1 BOTTLE; 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	09/11/2013

Labeler - Amway Corp (083416854)