RETIN C- 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

A cream with high concentrations of Vitamin A, Vitamin C and marine collagen, which are particularly indicated for oily and aging skin. It combines the regenerating action of Retinol and the bateriostatic action of Vitamin C to fight premature skin aging. Softens and smoothes the skin, reduces wrinkles and gives the skin an even, radiant glow.

50ml. 1.7 fl. Oz

Warning

TOPICAL USE

RETIN C
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42248-105
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 mL in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE (UNII: NMQ347994Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)
LEMON JUICE (UNII: AGN709ANTJ)
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD) (UNII: 389H2R62BD)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TALC (UNII: 7SEV7J4R1U)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
SODIUM ASCORBATE (UNII: S033EH8359)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
MAGNESIUM SULFATE (UNII: DE08037SAB)
METHYLPARABEN (UNII: A2I8C7HI9T)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
TRICLOSAN (UNII: 4NM5039Y5X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description
Packaging
1	NDC:42248-105-02	1 in 1 BOX
1		50 mL in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/15/2011

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

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