MELAFADIN DAY PROTECTION- titanium dioxide, octinoxate, octocrylene cream

Melafadin Day Protection by

Drug Labeling and Warnings

Melafadin Day Protection by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide: .99%, Octinoxate: 7.49% and Octocrylene: 6.0% Purpose: Sunscreen

Ingredients:

AQUA [WATER], PROPYLHEPTYL CAPRYLATE, ALCOHOL DENAT., BUTYLENE GLYCOL, NYLON-12, CAPRYLIC/CAPRIC TRIGLYCERIDE,GLYCERIN, CETEARYL ALCOHOL, ARACHIDYL ALCOHOL, SACCHARIDE ISOMERATE, TRICONTANYL PVP, METHYLENE , BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, BIS-ETHYLHEXYLOXYPHENOL, METHOXYPHENYL TRIAZINE, ETHYLHEXYL TRIAZONE, SIGESBECKIA ORIENTALIS EXTRACT, RABDOSIA RUBESCENS EXTRACT, ALUMINUM HYDROXIDE, BEHENYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLUCOSE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, UNDECYLENOYL PHENYLALANINE, UNDECYLENIC ACID, DIACETYL BOLDINE, POLYISOBUTENE, SODIUM ACRYLATE/ , SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, XANTHAN GUM, CAPRYLYL/CAPRYL GLUCOSIDE, CETEARYL GLUCOSIDE, ARACHIDYL GLUCOSIDE, DECYL GLUCOSIDE, HYDROGEN DIMETHICONE,TOCOPHEROL, BHT, TETRASODIUM IMINODISUCCINATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, PROPYLENE GLYCOL,TROMETHAMINE, CITRIC ACID, PARFUM [FRAGRANCE], BUTYLPHENYL METHYLPROPIONAL, HEXYL CINNAMAL, ALPHA-ISOMETHYL IONONE, LINALOOL, GERANIOL, CITRONELLOL, PHENOXYETHANOL, METHYLPARABEN

Warnings

Warning: For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor.

Keep out of reach of children.

Directions

Distribute over the facial skin each morning

Outside Box Packaging

Image of 310 box

INGREDIENTS AND APPEARANCE

MELAFADIN DAY PROTECTION 
titanium dioxide, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	.30 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.80 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
ETHANOLAMINE OLEATE (UNII: U4RY8MRX7C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) (UNII: N0SS3Q238D)
BISOCTRIZOLE (UNII: 8NT850T0YS)
BEMOTRIZINOL (UNII: PWZ1720CBH)
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DOCOSANOL (UNII: 9G1OE216XY)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DEXTROSE (UNII: IY9XDZ35W2)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
DIACETYL BOLDINE (UNII: 37727Z7M0I)
POLYISOBUTYLENE (200000 MW) (UNII: Z6Y02I0591)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROMETHAMINE (UNII: 023C2WHX2V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-310-02	1 in 1 BOX
1	NDC: 24653-310-01	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	01/01/2013

Labeler - Janssen Cosmetics GmbH (499187946)

Registrant - Janssen Cosmetics GmbH (499187946)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmetics GmbH		499187946	manufacture(24653-310)