OPTIMAL TINTED COMPLEXION- ethylhexl methoxycinnamate cream

Optimal Tinted Complexion by

Drug Labeling and Warnings

Optimal Tinted Complexion by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients: ethylhexyl methoxycinnamate 7.0% Purpose: Sunscreen

Inactive Ingredients

Inactive Ingredients: Aqua [water], caprylic/capric triglyceride, butylene glycol, dicaprylyl carbonate, C12-15 alkyl benzoate, cetearyl

alcohol, methyl glucose sesquistearate, CI 77891 [titanium dioxide], glyceryl stearate, nylon-12, saccharide isomerate, ascorbyl

palmitate, BHT, tocopherol, lauroyl lysine, lecithin, disodium EDTA, citric acid, parfum [fragrance], hexyl cinnamal, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, alpha-isomethylionone, benzyl salicylate, citronellol, linalool, limonene, benzyl benzoate, phenoxyethanol, methylparaben, propylparaben,butylparaben, ethylparaben, isobutylparaben, CI 77 492 [iron oxides], CI 77 491 [iron oxides], CI 77 499 [iron oxides]

Warning Section

Avoid contact with eyes. Keep out of reach of children. For External use only. Does not replace the use of sun products in care of sun exposure

Ask Doctor Section

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

Direction:

Apply evenly onto cleansed skin in the morning. Ideal foundation for make-up

Principal Display

Principal Display Product Tube

INGREDIENTS AND APPEARANCE

OPTIMAL TINTED COMPLEXION 
ethylhexl methoxycinnamate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLUCAMETACIN (UNII: N1EXE5EHAN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NYLON-12 (UNII: 446U8J075B)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
LAUROYL LYSINE (UNII: 113171Q70B)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL BENZOATE (UNII: N863NB338G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-011-02	1 in 1 BOX
1	NDC: 24653-011-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/20/2012

Labeler - Janssen Cosmetics GmbH (499187946)

Registrant - Janssen Cosmetics GmbH (499187946)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmetics GmbH		499187946	manufacture(24653-011)