Label: CC SPF 18 FAIR- avobenzone, octinoxate cream
CC SPF 18 LIGHT TO MEDIUM- avobenzone, octinoxate cream
CC SPF 18 MEDIUM- avobenzone, octinoxate cream
CC SPF 18 MEDIUM TO DARK- avobenzone, 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 July 1, 2013

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Avobenzone 2.0%
    Octinoxate 7.5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external uses only

    Do not use on damaged or broken skin

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients

    Water (Aqua), Cyclotetrasiloxane, Cetearyl Alcohol, Polyglyceryl-4 Isostearate, Dromiceius Oil, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, DEA-Cetyl Phosphate, PEG-40 Castor Oil, Tocopheryl Acetate, Sodium Hyaluronate, Allantoin, Sodium Ascorbate, Carbomer, Magnesium Aluminum Silicate, Hexyl Laurate, Polysorbate 60, Phenoxyethanol, Sodium Dehydroacetate, Methylparaben, Isopropylparaben, Isobutylparaben, Butylparaben, [+/- (May Contain): Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Mica (CI 77019)]

  • Other information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - fair

    Dr Dennis Gross

    SKINCARE

    CC Cream
    Broad Spectrum
    SPF 18

    1.0 fl oz /30ml e

    Principal Display Panel - 30ml Tube Carton - fair
  • PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - light to medium

    Dr Dennis Gross

    SKINCARE

    CC Cream
    Broad Spectrum
    SPF 18

    1.0 fl oz /30ml e

    Principal Display Panel - 30ml Tube Carton - light to medium
  • PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - medium

    Dr Dennis Gross

    SKINCARE

    CC Cream
    Broad Spectrum
    SPF 18

    1.0 fl oz /30ml e

    Principal Display Panel - 30ml Tube Carton - medium
  • PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - medium to dark

    Dr Dennis Gross

    SKINCARE

    CC Cream
    Broad Spectrum
    SPF 18

    1.0 fl oz /30ml e

    Principal Display Panel - 30ml Tube Carton - medium to dark
  • INGREDIENTS AND APPEARANCE
    CC SPF 18   FAIR
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    EMU OIL (UNII: 344821WD61)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58633-231-101 in 1 CARTON
    130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2013
    CC SPF 18   LIGHT TO MEDIUM
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    EMU OIL (UNII: 344821WD61)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58633-232-101 in 1 CARTON
    130 mL in 1 TUBE
    2NDC:58633-232-607 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2013
    CC SPF 18   MEDIUM
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-233
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    EMU OIL (UNII: 344821WD61)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58633-233-101 in 1 CARTON
    130 mL in 1 TUBE
    2NDC:58633-233-607 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2013
    CC SPF 18   MEDIUM TO DARK
    avobenzone, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    EMU OIL (UNII: 344821WD61)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58633-234-101 in 1 CARTON
    130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/15/2013
    Labeler - Dr. Dennis Gross Skincare, LLC (008190808)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantis Laboratories, Inc194673984MANUFACTURE(58633-231, 58633-232, 58633-233, 58633-234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies and Packaging809172885PACK(58633-231, 58633-232, 58633-233, 58633-234)
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