ARTISTRY HYDRA V SHEER WEIGHTLESS FOUNDATION SHADE SOLEIL L3W1- octinoxate, zinc oxide cream

Artistry Hydra V Sheer Weightless Foundation Shade Soleil by

Drug Labeling and Warnings

Artistry Hydra V Sheer Weightless Foundation Shade Soleil by is a Otc medication manufactured, distributed, or labeled by Amway Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 4% (W/W P/P)

Zinc Oxide 2.74% (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 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
• 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: Sun Protection Measures.
• 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/AQUA/EAU, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NEOPENTYL GLYCOL DIHEPTANOATE, MICA (CI 77019), LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, TRIMETHYLSILOXYPENYL  DIMETHICONE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, PROPANEDIOL, GLYCERIN, C12-15 ALKYL BENZOATE, DIPHENYL DIMETHICONE,  SYNTHETIC FLUORPHLOGOPITE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, LECITHIN, HYDROXYACETOPHENONE, DISTEARDIMONIUM HECTORITE, POLYSILICONE-11, ALUMINA, POLYSORBATE-20, SODIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALCOHOL DENAT, PEG/PPG-18/18 DIMETHICONE, ISOCETETH-10, TRISILOXANE, TRIETHOXYCAPRYLYLSILANE, HYDROGEN DIMETHICONE, PHENOXYETHANOL, DISODIUM EDTA, SODIUM HYALURONATE, BUTYLENE GLYCOL, EUTERPE OLERACEA FRUIT OIL, LAURETH-12, DIPROPYLENE GLYCOL, BHT, TOCOPHEROL, CHLORPHENESIN, GLYCINE SOJA (SOYBEAN) OIL, CERAMIDE NP, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, BETA-SITOSTEROL, PROPYLENE GLYCOL, PERILLA OCYMOIDES SEED OIL, SALVIA HISPANICA SEED OIL, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, TETRAHEXYLDECYL ASCORBATE. MAY CONTAIN / PEUT CONTIENIR +/- IRON OXIDES (CI 77491, 77492, 77499), TITANIUM DIOXIDE (CI 77891).

Package Labeling:

INGREDIENTS AND APPEARANCE

ARTISTRY HYDRA V SHEER WEIGHTLESS FOUNDATION SHADE SOLEIL   L3W1
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	27.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
MICA (UNII: V8A1AW0880)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ALCOHOL (UNII: 3K9958V90M)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ISOCETETH-10 (UNII: 1K92T9919H)
TRISILOXANE (UNII: 9G1ZW13R0G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ACAI OIL (UNII: Z0W6766A2W)
LAURETH-12 (UNII: OAH19558U1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
CHLORPHENESIN (UNII: I670DAL4SZ)
SOYBEAN OIL (UNII: 241ATL177A)
CERAMIDE NP (UNII: 4370DF050B)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
CHIA SEED OIL (UNII: MC2LH51BO7)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-223-00	1 in 1 CARTON	09/23/2017
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/23/2017

Labeler - Amway Corp (083416854)