ITC CC FULL COVERAGE CREAM NEUTRAL MEDIUM- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM NEUTRAL TAN- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM FAIR LIGHT- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM LIGHT- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM MEDIUM- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM MEDIUM TAN- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM TAN- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM RICH HONEY- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM FAIR- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM LIGHT MEDIUM- titanium dioxide, zinc oxide cream ITC CC FULL COVERAGE CREAM RICH- titanium dioxide, zinc oxide cream

ITC CC Full Coverage Cream Rich by

Drug Labeling and Warnings

ITC CC Full Coverage Cream Rich by is a Otc medication manufactured, distributed, or labeled by Beauty Manufacturing Solutions Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium dioxide 9.0%

Zinc oxide 6.3%%

PURPOSE

sunscreen

INDICATIONS & USAGE

• 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 use only

DO NOT USE

keep out of eyes. Rinse with water to remove

ASK DOCTOR

rash occurs

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For sunscreen use:
● apply liberally 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a 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
● children under 6 months of age: Ask a doctor

STORAGE AND HANDLING

protect the product in this container from excessive heat and direct sun

QUESTIONS

Call 800-620-3950

INACTIVE INGREDIENT

water, snail secretion filtrate, phenyl trimethicone, dimethicone, butylene glycol, butylene glycol dicaprylated/dicaprate, orbignya oleifera seed oil, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethiocone, cyclopentasiloxane, cyclohexasiloxane, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, aluminum hydroxide, hexyl laurate, stearic acid, calcium stearate, caprylyl glycol, triethoxycaprylylsilane, ethylhexylglycerin, citrus medica limonum (lemon) peel oil, tocopheryl acetate, sorbitan isostearate, phenoxyethanol, citrus aurantium bergamia (bergamot) fruit oil, 1,2-hexanediol, disodium EDTA, citrus aurantium dulcis (orange) peel oil, cirus aurantifolia (lime) oil vitis vinifera (grape) seed oil, punica gratissiima (avocado) oil, niacinamide, citrus grandis (grapefuit) peel oil, chloesterol, anthemis b=nobilis flower water, lactobacillius/honeysuckle flowr/locorice root/morus alba root/pueraria lobata root/schizandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, perfluorohexane, olea europaea (olive) leaf extract, glycerin, eucalyptus globulus leaf oil, camellia sinensis leaf extract, chrysanthemium indicum flower extract, pueraria lobata root extract, perfluorodecalin, morus alba gruit extract, magnolia kobus bark extract, glycine soja (soybean) sprout extract, diospyros kaki leaf extract, cinnamomum cassia bark extract, artemisia princeps leaf extract, epntafluoropropane, curcuma longa (turmeric) root extract, steareth-20, hydrolyzed silk, hydrolyzed hyaluronic acid, colloidal oatmeal, citric acid, sodium benzoate, potassum sorbate, aloe barbadensis leaf extract, n-hydroxysuccinimide, hydrolyzed collagen, caprylhydroxamic acid, tocopherol, thiamine HCL, riboflavin, retinyl palmitate, pantothenic acid, palmitoyl oligopeptide, nicin, folic acid, chrysin, carnitine HCL, biotin, ascorbic acid, palmitoyl tetrapeptide-7, chlorhexidine digluconate; may contain: iron oxides

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ITC CC FULL COVERAGE CREAM NEUTRAL MEDIUM 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-108-01	1 in 1 CARTON	03/14/2018
1		12 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-108-03	1 in 1 CARTON	03/14/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-108-02	1 in 1 CARTON	03/14/2018
3		32 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM NEUTRAL TAN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-110-01	1 in 1 CARTON	03/14/2018
1		12 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-110-03	1 in 1 CARTON	03/14/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-110-02	1 in 1 CARTON	03/14/2018
3		32 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM FAIR LIGHT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-104-01	1 in 1 CARTON	03/14/2018
1		12 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-104-03	1 in 1 CARTON	03/14/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-104-02	1 in 1 CARTON	03/14/2018
3		32 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM LIGHT 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-105-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-105-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-105-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-105-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM MEDIUM 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-107-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-107-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-107-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-107-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM MEDIUM TAN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-109-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-109-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-109-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-109-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM TAN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-111-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-111-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-111-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-111-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM RICH HONEY 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-113-01	1 in 1 CARTON	03/14/2018
1		12 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-113-03	1 in 1 CARTON	03/14/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-113-02	1 in 1 CARTON	03/14/2018
3		32 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM FAIR 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-103-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-103-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-103-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-103-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM LIGHT MEDIUM 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-106-01	1 in 1 CARTON	03/14/2018
1		12 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-106-03	1 in 1 CARTON	03/14/2018
2		75 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-106-02	1 in 1 CARTON	03/14/2018
3		32 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 final	part352	03/14/2018

ITC CC FULL COVERAGE CREAM RICH 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11090-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	63 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEMON OIL (UNII: I9GRO824LL)
STEARETH-20 (UNII: L0Q8IK9E08)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CHRYSIN (UNII: 3CN01F5ZJ5)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CALCIUM STEARATE (UNII: 776XM7047L)
BABASSU OIL (UNII: 8QSB4M5477)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ADENOSINE (UNII: K72T3FS567)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
LIME OIL (UNII: UZH29XGA8G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
OATMEAL (UNII: 8PI54V663Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
WATER (UNII: 059QF0KO0R)
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ORANGE OIL (UNII: AKN3KSD11B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11090-112-01	1 in 1 CARTON	03/14/2018
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11090-112-02	1 in 1 CARTON	03/14/2018
2		12 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11090-112-03	1 in 1 CARTON	03/14/2018
3		32 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11090-112-04	1 in 1 CARTON	03/14/2018
4		75 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 final	part352	03/14/2018

Labeler - Beauty Manufacturing Solutions Corp. (783200723)

Registrant - Beauty Manufacturing Solutions Corp. (783200723)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(11090-103, 11090-104, 11090-105, 11090-106, 11090-107, 11090-108, 11090-109, 11090-110, 11090-111, 11090-112, 11090-113)