PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM- dimethicone cream 
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Dimethicone 5.00%

Skin Protectant

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

Apply liberally as needed onto skin

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.

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

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

image description

PRESTIGE CAVIAR ESSENTIAL BARRIER EYE CREAM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70519-001-021 in 1 PACKAGE06/27/2017
1NDC:70519-001-0130 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/27/2017
Labeler - FW1 R&D_Branch (689605458)
Registrant - FW1 R&D_Branch (689605458)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(70519-001)

Revised: 6/2017
Document Id: 5ad27514-9b8c-4526-8426-35cbca2d0a67
Set id: c310c3af-abc5-437e-8c0c-6bc880103579
Version: 3
Effective Time: 20170627
 
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