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

ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 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

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, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISONONYL ISONONANOATE, BUTYLENE GLYCOL, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, SQUALANE, GLYCERYL STEARATE, ISOSTEARYL PALMITATE, PEG-100 STEARATE, TOCOPHERYL ACETATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, CETYL ALCOHOL, ARACHIDYL GLUCOSIDE, CHLORPHENESIN, METHYLPARABEN, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, DIMETHICONE, FRAGRANCE/PARFUM, DISODIUM EDTA, OZOKERITE, POLYSORBATE 60, GLYCINE SOJA (SOYBEAN) OIL, PANTHENOL, TOCOPHEROL, ACETYL HYDROXYPROLINE, ARGININE, PROPYLENE GLYCOL, STEARYL GLYCYRRHETINATE, CAMELLIA SINENSIS LEAF EXTRACT, LECITHIN, DIPOTASSIUM GLYCYRRHIZATE, PYRUS COMMUNIS (PEAR) FRUIT EXTRACT, FERULA ASSA FOETIDA ROOT EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, SODIUM HYALURONATE, ADANSONIA DIGITATA FRUIT EXTRACT, SERICIN, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, POLYGLUTAMIC ACID, CERAMIDE 3, LIMNANTHES ALBA
(MEADOWFOAM) SEED OIL, BETASITOSTEROL, RIBES NIGRUM (BLACK CURRANT) FRUIT EXTRACT, PERILLA OCYMOIDES SEED OIL, SALVIA HISPANICA SEED OIL, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, MALTODEXTRIN, TETRAHEXYLDECYL ASCORBATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACTPERILLA 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 SUNSCREEN 
octinoxate,avobenzone,oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
DOCOSANOL (UNII: 9G1OE216XY)
SQUALANE (UNII: GW89575KF9)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
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)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CHIA SEED OIL (UNII: MC2LH51BO7)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-112-00	50 g 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(50390-112)