LONG LAST MAKE UP 02 (NEO HELIOPAN) - ethylhexyl methoxycinnamate 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.

----------

Drug Facts

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

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]

Avoid contact with eyes.

Keep out of reach of children.

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

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


Outside box

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


Inside bottle

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

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

Revised: 1/2011
Document Id: 2fe6a69b-2f80-49f0-818c-4912d6302c91
Set id: 9af2122f-a3fb-4730-9d91-5e0f973811e6
Version: 7
Effective Time: 20110107
 
Janssen Cosmetics GmbH