HYDROMARINE EXTREME- octinoxate cream

Hydromarine by

Drug Labeling and Warnings

Hydromarine by is a Otc medication manufactured, distributed, or labeled by Zenith Medicosm SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Octinoxate 7.5%

Description

Light-texture day/night cream with marine collagen, hyaluronic acid and reaffermine that provides a natural level of hydration and all the nutrients required to keep your skin working perfectly.

200ml. 6.8 Fl.Oz.

Warning

TOPICAL USE

PROFESSIONAL ONLY

Instructions for use

After applying COLLAGEN HYDROMARINE EXTREME SERUM, rub the CREAM in gently until absorbed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROMARINE  EXTREME
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	15 mL  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
TRICHLOROETHANE (UNII: 113C650IR1)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
DIMETHICONE (UNII: 92RU3N3Y1O)
SOYBEAN (UNII: L7HT8F1ZOD)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BRONOPOL (UNII: 6PU1E16C9W)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLPARABEN (UNII: A2I8C7HI9T)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-110-01	200 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/15/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Establishment
Name	Address	ID/FEI	Business Operations
Zenith Medicosm SL		464239694	manufacture