PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM- dimethicone cream

Prestige Caviar Essential Barrier Eye Cream by

Drug Labeling and Warnings

Prestige Caviar Essential Barrier Eye Cream by is a Otc medication manufactured, distributed, or labeled by FW1 R&D_Branch, Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone 5.00%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

An eye treatment that moisturizes and helps minimize the look of dark circles,
shadows, and puffiness

DOSAGE & ADMINISTRATION

Apply liberally as needed onto skin

WARNINGS

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove
Stop using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

Caviar Extract, Petrolatum, Glycerin, Butyrospermum Parkii (Shea) Butter, Ceresin, Phenyl Trimethicone, Water, Polyglyceryl-2 Dipolyhydroxystearate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Niacinamide, Pentylene Glycol, Beeswax, Sodium Chloride, 1,2-Hexanediol, Silica, PEG-7 Dimethicone, Hydroxystearic Acid, Phenoxyethanol, Fragrance(Parfum), Disodium EDTA, Adenosine, Iron Oxides (CI 77499), Aqua, Hydrolyzed Rice Protein, Sodium Benzoate, Superoxide Dismutase, Glycine Soja (Soybean) Protein, Polydecene, Saccharide Isomerate, Sodium Dextran Sulfate, Potassium Sorbate, Caprylic/Capric Triglyceride, Sorbitan Laurate, Squalane, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Sodium Citrate, Citric Acid, Prunus Persica (Peach) Flower Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70519-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
CERESIN (UNII: Q1LS2UJO3A)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
YELLOW WAX (UNII: 2ZA36H0S2V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEDISMASE (UNII: 0786H5RV0T)
SOY PROTEIN (UNII: R44IWB3RN5)
HYDROGENATED DIDECENE (UNII: 048B98MT5O)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
SQUALANE (UNII: GW89575KF9)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)
CERAMIDE NP (UNII: 4370DF050B)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70519-001-02	1 in 1 PACKAGE	06/27/2017
1	NDC: 70519-001-01	30 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/27/2017

Labeler - FW1 R&D_Branch (689605458)

Registrant - FW1 R&D_Branch (689605458)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(70519-001)