HYALURONIC FILLER SERUM- octinoxate cream

Hyaluronic Filler by

Drug Labeling and Warnings

Hyaluronic Filler by is a Otc medication manufactured, distributed, or labeled by Zenith Medicosm SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYALURONIC FILLER  SERUM
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-125-02	1 in 1 BOX
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

Establishment
Name	Address	ID/FEI	Business Operations
Zenith Medicosm SL		464239694	manufacture