Label: MELAFADIN DAY PROTECTION- titanium dioxide, octinoxate and octocrylene cream

  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active Ingredients

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

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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

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  • 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.

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  • Directions

    Distribute over the facial skin each morning

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  • Outside Box Packaging

    Image of 310 box

    310 Box

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  • 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 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)
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