MELAFADIN DAY PROTECTION- titanium dioxide, octinoxate and octocrylene cream 
Janssen Cosmetics GmbH

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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Melafadin Day Protection

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

310 Box

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 DEA Schedule     
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)

Revised: 1/2013
Document Id: aebad75e-f667-4806-a5aa-e9bd0576fc28
Set id: ff80bdf2-ed0c-4914-bf13-39997cba1d3a
Version: 2
Effective Time: 20130116
 
Janssen Cosmetics GmbH