Label: LONG LAST MAKE UP 02 (NEO HELIOPAN)- ethylhexyl methoxycinnamate cream

  • 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 7, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients:   ethylhexyl methoxycinnamate 6,0%       Purpose: Sunscreen

  • INACTIVE INGREDIENT

    Inactive  Ingredients: Aqua [water], isohexadecane, cyclopentasiloxane,butylene glycol, tricaprylin, cetyl PEG/PPG-10/1 dimethicone, silica, cyclohexasiloxane, saccharide isomerate, dicaprylyl carbonate, polyglyceryl-4, isostearate, panthenol, lauroyl lysine, hydro-genated castor oil, disteardimonium hectorite, lecithin, ascorbylpalmitate, BHT, tocopherol, sodium chloride, cera microcristallina [microcrystalline wax], disodium EDTA, propylene carbonate, citric acid, parfum [fragrance], benzyl salicylate, hydroxyisohexyl 3-cyclohexene carboxaldehyde, hydroxycitronellal, limonene, alpha-isomethyl ionone, coumarin, linalool,phenoxyethanol, methylparaben,ethylparaben, propylparaben, butylparaben,isobutylparaben, CI77 891 [titanium dioxide], CI 77491 [iron oxides],CI 77 492 [iron oxides], CI 77 499 [iron oxides]

  • DO NOT USE

    Avoid contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    For External use only. Does not replace the use of sun products in case of sun exposure

  • STOP USE

    Discontinue use and consult a doctor if signs of rash or irritation develops and persists

  • Directions

    Apply evenly onto cleansed skin, ideally on top of a day cream

  • PRINCIPAL DISPLAY PANEL


    Outside box

    Janssen Cosmeceutical
    Make Up
    Long Lasting Makeup SPF 10
    Net 1.0 Fl. oz. 30ml

  • PRINCIPAL DISPLAY PANEL


    Inside bottle

    Janssen Cosmeceutical
    Make Up
    Long Lasting Makeup SPF 10
    Net 1.0 Fl oz. 30ml

  • INGREDIENTS AND APPEARANCE
    LONG LAST MAKE UP 02 (NEO HELIOPAN) 
    ethylhexyl methoxycinnamate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRICAPRYLIN (UNII: 6P92858988)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    HECTORITE (UNII: 08X4KI73EZ)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    IONONE (UNII: QP734LIN1K)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24653-805-021 in 1 CARTON
    1NDC:24653-805-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/10/2008
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmeceutical LLC (052993438)
    Establishment
    NameAddressID/FEIBusiness Operations
    Janssen Cosmecetics GmbH499187946manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Sacher Kosmetik GmbH341926681api manufacture
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