OPTIMAL TINTED COMPLEXION- 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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Optimal Tinted Complexion Cream

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

Packaging

Principal Display Product Tube

Tube Packaging

OPTIMAL TINTED COMPLEXION 
ethylhexl methoxycinnamate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24653-011
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2012
Document Id: 77ae783e-cda1-4c8b-9c25-d3d3a9fd8a3a
Set id: fce481ed-94ef-4c80-a029-b6885d5c5092
Version: 4
Effective Time: 20120920
 
Janssen Cosmetics GmbH