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
-
Contains inactivated NDC Code(s)
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
- 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.
- 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
-
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
- 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
-
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 1 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2013 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 1 30 mL in 1 TUBE 2 NDC:58633-232-60 7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2013 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 1 30 mL in 1 TUBE 2 NDC:58633-233-60 7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2013 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 1 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/15/2013 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)