PRESTIGE CAVIAR FULL MOISTURIZING EMULSION- dimethicone emulsion

Prestige Caviar Full Moisturizing Emulsion by

Drug Labeling and Warnings

Prestige Caviar Full Moisturizing Emulsion 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 2.00%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Helps to prevent dehydration of skin

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, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRESTIGE CAVIAR FULL MOISTURIZING EMULSION 
dimethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70519-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.6 mg  in 130 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70519-003-02	1 in 1 PACKAGE	06/27/2017
1	NDC: 70519-003-01	130 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(70519-003)