HYDROMARINE EXTREME- octinoxate cream 
Zenith Medicosm SL

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

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.

Hydromarine Extreme

HYDROMARINE  EXTREME
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE15 mL  in 200 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42248-110-01200 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/15/2011
Labeler - Zenith Medicosm SL (464239694)
Registrant - Zenith Medicosm SL (464239694)
Establishment
NameAddressID/FEIBusiness Operations
Zenith Medicosm SL464239694manufacture

Revised: 1/2012
Document Id: fba51ef7-8b81-4b54-9707-b2c75667b4a5
Set id: 08aa016c-53af-47dc-9dd7-c497ea62b587
Version: 5
Effective Time: 20120121
 
Zenith Medicosm SL