ARTISTRY TIME DEFIANCE UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN- octinoxate, zinc oxide, octisalate,titanium dioxide cream

ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen by

Drug Labeling and Warnings

ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by Amway Corp, Kolmar Korea Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen

Active Ingredients

OCTINOXATE 7.5%, ZINC OXIDE 6.528%, OCTISALATE 5.0%, TITANIUM DIOXIDE 2.49%

Other Ingredients

WATER , CYCLOPENTASILOXANE , ALCOHOL DENAT., BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, ISODECYL NEOPENTANOATE, METHYL METHACRYLATE CROSSPOLYMER, PEG-10 DIMETHICONE, MAGNESIUM SULFATE, VINYL DIMETHICONE / METHI CONE SILSESQUIOXANE CROSSPOLYMER, CALCIUM ALUMINUM BOROSILI CATE , PHENOXYETHANOL , METHICONE , ALUMINUM HYDROXIDE , ALUMINUM STEARATE, FRAGRANCE, METHYLPARABEN, POLYGLY CERYL -6 POLYRI CINOLEATE , PROPLYPARABEN, MICROCRYSTALLINE CELLULOSE, BUTYLPARABEN, GLYCERIN, CELLULOSE GUM, HYDROLYZED OATS, ARCTOSTAPHYLOS UVA
URSI LEAF EXTRA CT, CAMELLIA SINENSIS LEAF EXTRA CT, DIPOTASSIUM GLY CYRRHI ZATE, MAGNESIUM ASCORBYL PHOSPHATE, LACTOBACILLUS/ ACEROLA CHERRY FERMENT, HYDROLYZED POTATO PROTEIN, CITRUS AURANTIUM AMARA (BITTER ORANGE ) PEEL EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA), FLOWER EXTRACT, ERGOTHIONEINE

To Use:

SHAKE BOTTLE WELL. AFTER APPLYING MOISTURIZER, SMOOTH A LIBERAL AMOUNT OVER FACE AND NECK WITH YOUR FINGERTIPS. USE EVERY MORNING.

Use:

Helps prevent sunburn

Warnings:

• For external use only.
• Keep out of eyes.
• Stop use if rash or irritation develops
• Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away .

Directions:

For use as a sunscreen:
Apply liberally before sun exposure and as needed
Children under 6 months of age: Ask a doctor

MADE IN KOREA 1029785 DIST. BY AMWAY CORP., ADA, MI 49355 WWW.AMWAY.COM/SHOPARTISTRY

ARTISTRY® TIME DEFIANCE® UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN

Help keep your skin looking younger longer by protecting it with this high-level sunscreen. Moisturizing and fast absorbing, it works during the highest levels of sun exposure to deflect damaging rays and environmental assaults.

Shields skin against dark spots and discoloration. An exclusive Balanced Brightening Complex of 10 extracts, including white tea extract, helps give your skin a luminous glow. This lightweight, water-resistant formula creates the perfect base for makeup to glide on.

To use: Shake bottle well. After applying moisturizer, smooth a liberal amount over face and neck with your fingertips. Use every morning.

Smooth on as the final step in your ARTISTRY TIME DEFIANCE skincare regimen and before applying foundation.

Dermatologist- and allergy-tested. Suitable for use on sensitive skin. Non-acnegenic.

ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen 30ml/1oz (

50390-110-30)

INGREDIENTS AND APPEARANCE

ARTISTRY TIME DEFIANCE UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN 
octinoxate, zinc oxide, octisalate,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.528 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.49 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
METHYL METHACRYLATE (UNII: 196OC77688)
MAGNESIUM SULFATE (UNII: DE08037SAB)
CALCIUM ALUMINOSILICATE (UNII: 3L00JH8411)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
OAT (UNII: Z6J799EAJK)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ACEROLA (UNII: XDD2WEC9L5)
POTATO (UNII: CFE1S8DYWD)
CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)
CHAMOMILE (UNII: FGL3685T2X)
ERGOTHIONEINE (UNII: BDZ3DQM98W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-110-30	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/10/2012

Labeler - Amway Corp (083416854)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co. Ltd.		687846360	manufacture