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Hyaluronic Filler Serum

Dosage form: cream
Ingredients: OCTINOXATE 2.25mL in 30mL
Labeler: Zenith Medicosm SL
NDC Code: 42248-125

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.

Drug Facts

Active Ingredient

Octinoxate 7.5%

Description

Serum with two forms of hyaluronic cid, peptide fillers and marine collagen that generates an instantaneous effect by restoring skin volume and visibly reducing wrinkles. Indicated for rough skin with deep wrinkles.

30 ml. 1 FL. Oz


Warning

TOPICAL USE

HYALURONIC FILLER  SERUM
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
PROPYLPARABEN 
ALPHA-TOCOPHEROL ACETATE 
PROPYLENE GLYCOL 
CYCLOMETHICONE 
DIMETHICONE 
WATER 
SORBITOL 
POLYSORBATE 20 
ALCOHOL 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
GLYCERIN 
TROLAMINE 
ISOBUTYLPARABEN 
ACRYLAMIDE 
SODIUM ACRYLATE 
DIMETHICONOL (250000 MW) 
PANTHENOL 
METHYLPARABEN 
COLLAGEN, SOLUBLE, FISH SKIN 
PHENOXYETHANOL 
HYALURONATE SODIUM 
HYALURONIC ACID 
ETHYLHEXYL PALMITATE 
TRIBEHENIN 
SORBITAN ISOSTEARATE 
PALMITOYL OLIGOPEPTIDE 
Packaging
#Item CodePackage Description
1NDC:42248-125-021 BOTTLE (BOTTLE) in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2011
Labeler - Zenith Medicosm SL (464239694)
Registrant - Zenith Medicosm SL (464239694)
Establishment
NameAddressID/FEIOperations
Zenith Medicosm SL464239694manufacture

Revised: 02/2012
 
Zenith Medicosm SL

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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