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.

50ml. 1.7 fl. Oz


Warning

TOPICAL USE

HYDROMARINE
HYDROMARINE  EXTREME
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 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:42248-101-021 in 1 BOX
150 mL in 1 JAR
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)

Revised: 1/2012
Document Id: a92c28f0-6829-455d-b4fc-2bacb6f346db
Set id: c82bd14a-9fe6-4b69-890d-aac56e0790bd
Version: 7
Effective Time: 20120121
 
Zenith Medicosm SL