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

CC Cream Medium by

Drug Labeling and Warnings

CC Cream Medium by is a Otc medication manufactured, distributed, or labeled by Janssen Cosmetics GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Front Panel of Box

Front Panel of Box

ACTIVE INGREDIENT

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.

INGREDIENTS AND APPEARANCE

CC CREAM LIGHT 
octocrylene and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.0 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-270-02	1 in 1 BOX
1	NDC: 24653-270-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CC CREAM MEDIUM 
octocrylene and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24653-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.0 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.25 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24653-271-02	1 in 1 BOX
1	NDC: 24653-271-01	30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

Labeler - Janssen Cosmetics GmbH (499187946)

Registrant - Janssen Cosmetics GmbH (499187946)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cosmetics GmbH		499187946	manufacture(24653-270, 24653-271)