CC CREAM LIGHT- octocrylene and octinoxate cream 
CC CREAM MEDIUM- octocrylene and 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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CC Cream

Front Panel of Box

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Front Panel of Box

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Active Ingredients:                                               Purpose:

Octocrylene 10 %                                                 Sunscreen
Ethylhexyl methoxycinnamate 7.5 %                    Sunscreen

Cosmetic Ingredients

Water, propylheptyl caprylate, butylene glycol, methyl glucose sesquistearate, sodium potassium aluminum silicate, steareth-21, BIS-ethylhexyloxyphenolmethoxyphenyl triazine, ethylhexyl triazone, glycerin, cetearyl alcohol, glyceryl stearate, phenyl trimethicone, lauroyl lysine, sigesbeckia orientalis extract, rabdosia rubescens extract, fomes officinalis [mushroom] extract, helianthus annuus [sunflower] seed oil, yeast extract, soy isoflavones, lepidium sativum sprout extract, retinyl palmitate, PEG-40 hydrogenated castor oil, polysorbate 80, lecithin, silica, sodium levulinate, levulinic acid, ascorbyl palmitate, BHT, tocopherol, disodium EDTA, alcohol, ethylhexylglycerin, citric acid, Fragrance, phenoxyethanol, sodium benzoate, sodium dehydracetate, titanium dioxide, iron oxides

Ask Doctor Section

Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor.

Warnings

For external use only. Not to be swallowed. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Keep out of reach of children.

Direction for use

Distribute over the facial skin in the morning.

CC CREAM LIGHT 
octocrylene and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-270
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
STEARETH-21 (UNII: 53J3F32P58)  
Bemotrizinol (UNII: PWZ1720CBH)  
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
LAUROYL LYSINE (UNII: 113171Q70B)  
ISODON RUBESCENS TOP (UNII: 03NNJ0PH79)  
CULTIVATED MUSHROOM (UNII: 54C8E6W6JY)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
YEAST (UNII: 3NY3SM6B8U)  
SOY ISOFLAVONES (UNII: 71B37NR06D)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
LEVULINIC ACID (UNII: RYX5QG61EI)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-270-021 in 1 BOX
1NDC:24653-270-0130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2014
CC CREAM MEDIUM 
octocrylene and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-271
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
STEARETH-21 (UNII: 53J3F32P58)  
Bemotrizinol (UNII: PWZ1720CBH)  
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
LAUROYL LYSINE (UNII: 113171Q70B)  
ISODON RUBESCENS TOP (UNII: 03NNJ0PH79)  
CULTIVATED MUSHROOM (UNII: 54C8E6W6JY)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
YEAST (UNII: 3NY3SM6B8U)  
SOY ISOFLAVONES (UNII: 71B37NR06D)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LEVULINATE (UNII: VK44E1MQU8)  
LEVULINIC ACID (UNII: RYX5QG61EI)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-271-021 in 1 BOX
1NDC:24653-271-0130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2014
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(24653-270, 24653-271)

Revised: 2/2014
Document Id: 17e64293-87d8-42db-a080-5ded3be0d591
Set id: 74b2ec2c-5211-4a88-954c-d530fbb60380
Version: 2
Effective Time: 20140210
 
Janssen Cosmetics GmbH