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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24653-310
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide.30 g  in 50 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE1.80 g  in 50 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE2.25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLHEPTYL CAPRYLATE 
ETHANOLAMINE OLEATE 
BUTYLENE GLYCOL 
NYLON-12 
MEDIUM-CHAIN TRIGLYCERIDES 
GLYCERIN 
CETOSTEARYL ALCOHOL 
ARACHIDYL ALCOHOL 
SACCHARIDE ISOMERATE 
TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) 
BISOCTRIZOLE 
BEMOTRIZINOL 
ETHYLHEXYL TRIAZONE 
ALUMINUM HYDROXIDE 
DOCOSANOL 
SUNFLOWER OIL 
DEXTROSE 
CHONDRUS CRISPUS 
UNDECYLENIC ACID 
DIACETYL BOLDINE 
POLYISOBUTYLENE (200000 MW) 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
XANTHAN GUM 
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE 
CETEARYL GLUCOSIDE 
ARACHIDYL GLUCOSIDE 
DECYL GLUCOSIDE 
BUTYLATED HYDROXYTOLUENE 
TETRASODIUM IMINODISUCCINATE 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
PROPYLENE GLYCOL 
TROMETHAMINE 
CITRIC ACID MONOHYDRATE 
BUTYLPHENYL METHYLPROPIONAL 
.ALPHA.-HEXYLCINNAMALDEHYDE 
ISOMETHYL-.ALPHA.-IONONE 
LINALOOL, (+/-)- 
GERANIOL 
.BETA.-CITRONELLOL, (R)- 
PHENOXYETHANOL 
METHYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-310-021 in 1 BOX
1NDC:24653-310-0150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2013
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(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