PRESTIGE CAVIAR FULL MOISTURIZING EMULSION- dimethicone emulsion 
FW1 R&D_Branch

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.

----------

Drug Facts

Dimethicone 2.00%

Skin Protectant

Helps to prevent dehydration of skin

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, Water, Glycerin, Butylene Glycol, Niacinamide, Pentaerythrityl Tetraethylhexanoate, 1,2-Hexanediol, Cyclopentasiloxane, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Pentylene Glycol, Hydrogenated Poly(C6-14 Olefin), Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, PEG-40 Stearate, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Fragrance(Parfum), Carbomer, Tromethamine, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate, Squalane, Adenosine, Dextrin, Theobroma Cacao (Cocoa) Extract, Disodium EDTA, Polysorbate 60, Imperata Cylindrica Root Extract, Sorbitan Isostearate, Polydecene, Gardenia Florida Fruit Extract, Saccharide Isomerate, Monascus Extract, PEG-8, Maltodextrin, Caprylic/Capric Triglyceride, Sorbitan Laurate, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Carthamus Tinctorius (Safflower) Flower Extract, Hydrolyzed Viola Tricolor Extract, Cassia Angustifolia Seed Polysaccharide, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Sodium Citrate

image description

PRESTIGE CAVIAR FULL MOISTURIZING EMULSION 
dimethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.6 mg  in 130 mL
Inactive Ingredients
Ingredient NameStrength
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
TROMETHAMINE (UNII: 023C2WHX2V)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
ADENOSINE (UNII: K72T3FS567)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
COCOA (UNII: D9108TZ9KG)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HYDROGENATED DIDECENE (UNII: 048B98MT5O)  
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
VIOLA TRICOLOR (UNII: 9Q24RAI43V)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70519-003-021 in 1 PACKAGE06/27/2017
1NDC:70519-003-01130 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(70519-003)

Revised: 6/2017
Document Id: 6d89eb4e-9249-4376-ab0a-c2289a6d8387
Set id: 2a953516-6714-46ec-a861-99fb2e20fa36
Version: 4
Effective Time: 20170627
 
FW1 R&D_Branch