PRESTIGE CAVIAR NOURISHING DAILY CREAM- glycerin, dimethicone cream

Prestige Caviar Nourishing Daily Cream by

Drug Labeling and Warnings

Prestige Caviar Nourishing Daily 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

Glycerin 27.36%
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, Cyclopentasiloxane, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Butylene Glycol, Glycereth-26, Niacinamide, 1,2-Hexanediol, PEG/PPG-19/19 Dimethicone, Methyl Gluceth-20, Sodium Glutamate, Phenoxyethanol, PEG-7 Dimethicone, PEG/PPG-20/20 Dimethicone, Fragrance(Parfum), Dipotassium Glycyrrhizate, Adenosine, Iron Oxides (CI 77499), Synthetic Fluorphlogopite, Sodium Citrate, C12-14 Pareth-12, Titanium Dioxide (CI 77891), Disodium EDTA, Aqua, Polydecene, Saccharide Isomerate, Hydrolyzed Rice Protein, Caprylic/Capric Triglyceride, Sorbitan Laurate, Squalane, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Sodium Benzoate, Superoxide Dismutase, Glycine Soja (Soybean) Protein, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Citric Acid, Sodium Dextran Sulfate, Potassium Sorbate, Prunus Persica (Peach) Flower Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRESTIGE CAVIAR NOURISHING DAILY CREAM 
glycerin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70519-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	13.7 mg  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERETH-26 (UNII: NNE56F2N14)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ADENOSINE (UNII: K72T3FS567)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
C12-14 PARETH-12 (UNII: M0LJS773XW)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGENATED DIDECENE (UNII: 048B98MT5O)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
SQUALANE (UNII: GW89575KF9)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
VISCUM ALBUM FRUIT (UNII: P83EQ521R3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LEDISMASE (UNII: 0786H5RV0T)
SOY PROTEIN (UNII: R44IWB3RN5)
CERAMIDE NP (UNII: 4370DF050B)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70519-004-02	1 in 1 PACKAGE	06/27/2017
1	NDC: 70519-004-01	50 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(70519-004)