Label: CC CREAM LIGHT- octocrylene and octinoxate cream
CC CREAM MEDIUM- octocrylene and octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24653-270-01, 24653-270-02, 24653-271-01, 24653-271-02 - Packager: Janssen Cosmetics GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 10, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Front Panel of Box
- Front Panel of Box
- ACTIVE INGREDIENT
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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
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- Warnings
- Direction for use
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INGREDIENTS AND APPEARANCE
CC CREAM LIGHT
octocrylene and octinoxate creamProduct 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 creamProduct 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)