Label: MELAFADIN DAY PROTECTION- titanium dioxide, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24653-310-01, 24653-310-02 - Packager: Janssen Cosmetics GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 16, 2013
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- Official Label (Printer Friendly)
- Active Ingredients
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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
- Directions
- Outside Box Packaging
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INGREDIENTS AND APPEARANCE
MELAFADIN DAY PROTECTION
titanium dioxide, octinoxate, octocrylene creamProduct 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)
