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

CC SPF 18 by

Drug Labeling and Warnings

CC SPF 18 by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare, LLC, Atlantis Laboratories, Inc, Process Technologies and Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 - 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 - 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

INGREDIENTS AND APPEARANCE

CC SPF 18   FAIR
avobenzone, octinoxate cream

Product 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 cream

Product 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 cream

Product 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 cream

Product 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)