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
Dr. Dennis Gross Skincare, LLC

----------

CC Cream SPF 18

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 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

CC SPF 18 FAIR
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58633-231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/15/2013	06/01/2024

CC SPF 18 LIGHT TO MEDIUM
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58633-232
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/15/2013	06/01/2024

CC SPF 18 MEDIUM
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58633-233
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/15/2013	06/01/2024

CC SPF 18 MEDIUM TO DARK
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58633-234
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/15/2013	06/01/2024

Labeler - Dr. Dennis Gross Skincare, LLC (008190808)

Name	Address	ID/FEI	Business Operations
Establishment
Atlantis Laboratories, Inc		194673984	MANUFACTURE(58633-231, 58633-232, 58633-233, 58633-234)

Name	Address	ID/FEI	Business Operations
Establishment
Process Technologies and Packaging		809172885	PACK(58633-231, 58633-232, 58633-233, 58633-234)

Revised: 5/2024

Document Id: a7ab904d-fc7a-4921-9365-cd5048225219

Set id: ac141a04-3e9a-4641-9c80-b8bdd6a0a81f

Version: 2

Effective Time: 20240507

Dr. Dennis Gross Skincare, LLC