HYALURONIC FILLER SERUM- 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

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

HYALURONICFILLER
HYALURONIC FILLER  SERUM
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALCOHOL (UNII: 3K9958V90M)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
ACRYLAMIDE (UNII: 20R035KLCI)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
PANTHENOL (UNII: WV9CM0O67Z)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HYALURONIC ACID (UNII: S270N0TRQY)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42248-125-021 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/FEIBusiness Operations
Zenith Medicosm SL464239694manufacture

Revised: 2/2012
Document Id: ed471670-2e13-4e44-8a0a-09a095c5a57c
Set id: e583236c-812c-4c4c-bc4b-edec71ab1083
Version: 1
Effective Time: 20120220
 
Zenith Medicosm SL