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.

----------

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24653-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
DICAPRYLYL CARBONATE 
C12-15 ALKYL BENZOATE 
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE 
CETOSTEARYL ALCOHOL 
GLUCAMETACIN 
GLYCERYL MONOSTEARATE 
NYLON-12 
SACCHARIDE ISOMERATE 
LAUROYL LYSINE 
EGG PHOSPHOLIPIDS 
ASCORBYL PALMITATE 
BUTYLATED HYDROXYTOLUENE 
TOCOPHEROL 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
.ALPHA.-HEXYLCINNAMALDEHYDE 
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE 
BUTYLPHENYL METHYLPROPIONAL 
ISOMETHYL-.ALPHA.-IONONE 
BENZYL SALICYLATE 
.BETA.-CITRONELLOL, (R)- 
LINALOOL, (+/-)- 
BENZYL BENZOATE 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
ISOBUTYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-011-021 in 1 BOX
1NDC:24653-011-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/20/2012
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(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