CALCIUM REPAIR- 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

Cream with excellent repairing effect containing calcium, marine collagen and hyaluronic acid. The extra calcium content helps recover skin density and support, and restructure and fight the premature signs of skin thinning typical of menopause. Indicated for all skin types.

50ml. 1.7 fl. Oz


Warning

TOPICAL USE

CALCIUMREPAIR
CALCIUM  REPAIR
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-104
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ROSA MOSCHATA OIL (UNII: J99W255AWF)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
TROLAMINE (UNII: 9O3K93S3TK)  
SOY ISOFLAVONES (UNII: 71B37NR06D)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CARBOMER 934 (UNII: Z135WT9208)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PANAX GINSENG FRUIT (UNII: E35T4MOI3E)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
ALLANTOIN (UNII: 344S277G0Z)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42248-104-021 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)
Establishment
NameAddressID/FEIBusiness Operations
Zenith Medicosm SL464239694manufacture

Revised: 1/2012
Document Id: b769397d-8e80-4d92-9e25-60301a2b4f54
Set id: f518bd48-fb0f-4d92-a793-2074000f95dc
Version: 4
Effective Time: 20120121
 
Zenith Medicosm SL