REGEMARINE EXTREME- octinoxate cream

Regemarine by

Drug Labeling and Warnings

Regemarine 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

The exclusive formula with marine collagen, algae and rosehip oil regenerates damaged tissue and helps firm and hydrate skin.  Specially designed for sagging and aged skin that requires progressive rejuvenation.

50ml. 1.7 fl. Oz

Warning

TOPICAL USE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REGEMARINE  EXTREME
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42248-107
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
SOYBEAN (UNII: L7HT8F1ZOD)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
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)
PEG/PPG-20/23 DIMETHICONE (UNII: XK68QT7HWY)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
PELVETIA CANALICULATA (UNII: 8U1M44KESN)
ALLANTOIN (UNII: 344S277G0Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42248-107-02	1 in 1 BOX
1		50 mL in 1 JAR

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

Labeler - Zenith Medicosm SL (464239694)

Registrant - Zenith Medicosm SL (464239694)

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