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

  • 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.

  • Front Panel of Box

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  • Front Panel of Box

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  • 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 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)