PRESTIGE CAVIAR NOURISHING DAILY CREAM- glycerin, dimethicone cream 
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.

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Drug Facts

Glycerin 27.36%
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, 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

image description

PRESTIGE CAVIAR NOURISHING DAILY CREAM 
glycerin, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13.7 mg  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70519-004-021 in 1 PACKAGE06/27/2017
1NDC:70519-004-0150 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(70519-004)

Revised: 6/2017
Document Id: 9196c80c-2fd3-4dce-928f-905f8edb6937
Set id: 172c07e9-09a2-46da-a3c1-f789ee437d6e
Version: 3
Effective Time: 20170627
 
FW1 R&D_Branch