ARTISTRY YOUTH XTEND PROTECTING BROAD SPECTRUM SPF 15- octinoxate,avobenzone,oxybenzone lotion

ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 by

Drug Labeling and Warnings

ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 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]

ARTISTRY YOUTH XTEND Protecting Lotion Broad Spectrum SPF 15

Active Ingredients

Octinoxate 7.5% (W/W P/P)
Avobenzone 3.0% (W/W P/P)
Oxybenzone 1.0% (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 sunscreen 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/EAU, GLYCERIN, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, ARACHIDYL ALCOHOL, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, TOCOPHERYL ACETATE, POTASSIUM CETYL PHOSPHATE, PEG-33, BEHENYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PEG-8 DIMETHICONE, HYDROGENATED PALM GLYCERIDES, SQUALANE, DICAPRYLYL ETHER, PEG-14, ARACHIDYL GLUCOSIDE, METHYLPARABEN, CHLORPHENESIN, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, PPG-15 STEARYL ETHER BENZOATE, PHENOXYETHANOL, FRAGRANCE/PARFUM, DISODIUM EDTA, GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER, POLYSORBATE 60, GLYCINE SOJA (SOYBEAN) OIL, PANTHENOL, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, ACETYL HYDROXYPROLINE, PROPYLENE GLYCOL, STEARYL GLYCYRRHETINATE, CAMELLIA SINENSIS LEAF EXTRACT, PROPYLPARABEN, LECITHIN, DIPOTASSIUM GLYCYRRHIZATE, PYRUS COMMUNIS (PEAR) FRUIT EXTRACT,FERULA ASSA FOETIDA ROOT EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, ETHYLPARABEN, SODIUM HYALURONATE, ADANSONIA DIGITATA FRUIT EXTRACT, SERICIN, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, POLYGLUTAMIC
ACID, CERAMIDE 3, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, BETA-SITOSTEROL, RIBES NIGRUM (BLACK CURRANT) FRUIT EXTRACT, PERILLA OCYMOIDES SEED OIL, SALVIA HISPANICA SEED OIL, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, MALTODEXTRIN, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT 

Package Labeling:

INGREDIENTS AND APPEARANCE

ARTISTRY YOUTH XTEND PROTECTING BROAD SPECTRUM SPF 15 
octinoxate,avobenzone,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PANTHENOL (UNII: WV9CM0O67Z)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
DOCOSANOL (UNII: 9G1OE216XY)
CHLORPHENESIN (UNII: I670DAL4SZ)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
METHYLPARABEN (UNII: A2I8C7HI9T)
ACEROLA (UNII: XDD2WEC9L5)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
BLACK CURRANT (UNII: 9755T40D11)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
PEAR (UNII: 2ZN8DWC0YF)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-113-00	50 mL in 1 JAR; Type 0: Not a Combination Product	05/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/06/2013

Labeler - Amway Corp (083416854)

Establishment
Name	Address	ID/FEI	Business Operations
Access Business Group LLC		839830713	manufacture(50390-113)