LONG LAST MAKEUP 00- octinoxate cream LONG LAST MAKEUP 01- octinoxate cream LONG LAST MAKEUP 05- octinoxate cream LONG LAST MAKEUP 03- octinoxate cream

Long Last Makeup 03 by

Drug Labeling and Warnings

Long Last Makeup 03 by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH, Janssen Cosmecetics GmbH, Dr. Sacher Kosmetik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Long Lasting Makeup 01 30ml pump bottle -8301

Long Lasting Makeup 03 -30ml pump bottle -8303

Long Lasting Makeup 05 - 30ml pump bottle - 8305

INGREDIENTS AND APPEARANCE

LONG LAST MAKEUP 00 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-800-02	1 in 1 CARTON
1	NDC: 24653-800-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/05/2012

LONG LAST MAKEUP 01 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-801-02	1 in 1 CARTON
1	NDC: 24653-801-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2008

LONG LAST MAKEUP 05 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-802-02	1 in 1 CARTON
1	NDC: 24653-802-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/10/2012

LONG LAST MAKEUP 03 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-803-02	1 in 1 CARTON
1	NDC: 24653-803-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2008

Labeler - Janssen Cosmetics GmbH (499187946)

Registrant - Janssen Cosmetics GmbH (499187946)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmecetics GmbH		499187946	manufacture(24653-800)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Sacher Kosmetik GmbH		341926681	api manufacture(24653-800)