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
-
NDC Code(s):
58633-231-10,
58633-232-10,
58633-232-60,
58633-233-10, view more58633-233-60, 58633-234-10
- Packager: Dr. Dennis Gross Skincare, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 7, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - fair
- PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - light to medium
- PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - medium
- PRINCIPAL DISPLAY PANEL - 30ml Tube Carton - medium to dark
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INGREDIENTS AND APPEARANCE
CC SPF 18 FAIR
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58633-231 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58633-231-10 1 in 1 CARTON 07/15/2013 06/01/2024 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2013 06/01/2024 CC SPF 18 LIGHT TO MEDIUM
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58633-232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58633-232-10 1 in 1 CARTON 07/15/2013 06/01/2024 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58633-232-60 7 mL in 1 TUBE; Type 0: Not a Combination Product 07/15/2013 06/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2013 06/01/2024 CC SPF 18 MEDIUM
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58633-233 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58633-233-10 1 in 1 CARTON 07/15/2013 06/01/2024 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58633-233-60 7 mL in 1 TUBE; Type 0: Not a Combination Product 07/15/2013 06/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2013 06/01/2024 CC SPF 18 MEDIUM TO DARK
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58633-234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58633-234-10 1 in 1 CARTON 07/15/2013 06/01/2024 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 07/15/2013 06/01/2024 Labeler - Dr. Dennis Gross Skincare, LLC (008190808) Establishment Name Address ID/FEI Business Operations Atlantis Laboratories, Inc 194673984 MANUFACTURE(58633-231, 58633-232, 58633-233, 58633-234) Establishment Name Address ID/FEI Business Operations Process Technologies and Packaging 809172885 PACK(58633-231, 58633-232, 58633-233, 58633-234)
