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.

200ml. 6.8Fl.Oz


Warning

TOPICAL USE

PROFESSIONAL ONLY

Instructions for use:

After applying LIFTINGMARINE EXTRACT, rub the cream into the skin until it is completely absorbed.

CALCIUM
CALCIUM  REPAIR
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-116
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
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:42248-116-01200 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: bf9ac16a-ea55-4129-8da4-fd0420d08865
Set id: 3de25e74-52b9-4888-a3ca-e12fbe1d243d
Version: 4
Effective Time: 20120121
 
Zenith Medicosm SL