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

Long Last Make UP 02 (Neo Heliopan) by

Drug Labeling and Warnings

Long Last Make UP 02 (Neo Heliopan) by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH, Janssen Cosmeceutical LLC, Janssen Cosmecetics GmbH, Dr. Sacher Kosmetik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-805-02	1 in 1 CARTON
1	NDC: 24653-805-01	30 mL in 1 BOTTLE

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 Cosmeceutical LLC (052993438)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmecetics GmbH		499187946	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Sacher Kosmetik GmbH		341926681	api manufacture