LONG LAST MAKEUP 00- octinoxate cream 
LONG LAST MAKEUP 01- octinoxate cream 
LONG LAST MAKEUP 05- octinoxate cream 
LONG LAST MAKEUP 03- octinoxate 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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Long Last Makeup

Drug Facts:

Active Ingredient: Ethylhexyl methoxycinnamate . . . . . . . . . . 6% Purpose: Sunscreen

Inactive Ingredient

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, hydrogenated castor oil, disteardimonium hectorite, lecithin, ascorbyl palmitate, 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, CI 77 891 [titanium dioxide], CI 77 491 [iron oxides], CI 77 492 [iron oxides], CI 77 499 [iron oxides]

Ask Doctor Section

Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor

Purpose of Use

For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

Keep out of reach

Keep out of reach of children

Long Last Make UP 00 30ml bottle - 8300

8300

Long Lasting Makeup 01 30ml pump bottle -8301

8301

Long Lasting Makeup 03 -30ml pump bottle -8303

8303

Long Lasting Makeup 05 - 30ml pump bottle - 8305

8305

LONG LAST MAKEUP 00 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRICAPRYLIN (UNII: 6P92858988)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PANTHENOL (UNII: WV9CM0O67Z)  
LAUROYL LYSINE (UNII: 113171Q70B)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
COUMARIN (UNII: A4VZ22K1WT)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-800-021 in 1 CARTON
1NDC:24653-800-0130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/05/2012
LONG LAST MAKEUP 01 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRICAPRYLIN (UNII: 6P92858988)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PANTHENOL (UNII: WV9CM0O67Z)  
LAUROYL LYSINE (UNII: 113171Q70B)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
COUMARIN (UNII: A4VZ22K1WT)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-801-021 in 1 CARTON
1NDC:24653-801-0130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/10/2008
LONG LAST MAKEUP 05 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRICAPRYLIN (UNII: 6P92858988)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PANTHENOL (UNII: WV9CM0O67Z)  
LAUROYL LYSINE (UNII: 113171Q70B)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
COUMARIN (UNII: A4VZ22K1WT)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-802-021 in 1 CARTON
1NDC:24653-802-0130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/10/2012
LONG LAST MAKEUP 03 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-803
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRICAPRYLIN (UNII: 6P92858988)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PANTHENOL (UNII: WV9CM0O67Z)  
LAUROYL LYSINE (UNII: 113171Q70B)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
COUMARIN (UNII: A4VZ22K1WT)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-803-021 in 1 CARTON
1NDC:24653-803-0130 mL in 1 BOTTLE, PUMP
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 Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmecetics GmbH499187946manufacture(24653-800)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Sacher Kosmetik GmbH341926681api manufacture(24653-800)

Revised: 10/2012
Document Id: 710340a0-3f2f-4355-8851-03998a2ba8a4
Set id: 99dbb0b2-28af-4d23-a5e3-352886cf1ea6
Version: 10
Effective Time: 20121011
 
Janssen Cosmetics GmbH