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

NDC Code(s): 11090-251-01, 11090-251-02, 11090-252-01, 11090-252-02, view more
11090-253-01, 11090-253-02, 11090-254-01, 11090-254-02, 11090-255-01, 11090-255-02, 11090-256-01, 11090-256-02, 11090-257-01, 11090-257-02, 11090-258-01, 11090-258-02, 11090-259-01, 11090-259-02, 11090-260-01, 11090-260-02, 11090-261-01, 11090-261-02, 11090-262-01, 11090-262-02
Packager: Beauty Manufacturing Solutions Corp

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph 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 February 12, 2022

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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ACTIVE INGREDIENT

Titanium Oxide 9%, Zinc Oxide 6.3%

Purpuse: Sunscreen
PURPOSE

Suncreen
INDICATIONS & USAGE

Helps Prevent Sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging by the sun.
WARNINGS

For external use only
DO NOT USE

on damaged or broken skin
STOP USE

if rash occurs
KEEP OUT OF REACH OF CHILDREN

if swallowed, get medical help or contact posion control center right away.
DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2hours.

Use a water resistant sunscreen is swimming or sweating.

Sun Protection Measures. SSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausures including: limit time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

children under 6mo of age:ask a doctor
STORAGE AND HANDLING

Protect the product in this container from execessive heat and direct sun.
INACTIVE INGREDIENT

N-HYDROXYSUCCINIMIDE, ETHYLHEXYLGLYCERIN, ADENOSINE, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL, CALCIUM STEARATE, GREEN TEA LEAF, CAPRYLYL GLYCOL, ALPHA-TOCOPHEROL ACETATE, LEMON OIL, HEXYL LAURATE, MAGNESIUM SULFATE HEPTAHYDRATE, MICA, OLEA EUROPAEA LEAF, BABASSU OIL, PALMITOYL TETRAPEPTIDE-7, ORANGE OIL, CYCLOMETHICONE 5, OATMEAL, CYCLOMETHICONE 6, POTASSIUM SORBATE, SORBITAN ISOSTEARATE, STEARETH-20, PINE NEEDLE OIL (PINUS SYLVESTRIS), POLYGLYCERYL-4 ISOSTEARATE, BOMBYX MORI FIBER, GIANT AFRICAN SNAIL, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, WATER, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CHLORHEXIDINE GLUCONATE, FERRIC OXIDE RED, DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE), EUCALYPTUS OIL, FERRIC OXIDE YELLOW, FERROSOFERRIC OXIDE, CHRYSIN, NIACINAMIDE, CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5), LIME OIL, BERGAMOT OIL, HYALURONIC ACID, GLYCERIN, TITANIUM DIOXIDE, BUTYLOCTYL SALICYLATE, 1,2-HEXANEDIOL, GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000), PHENYL TRIMETHICONE, PHENOXYETHANOL, PALMITOYL TRIPEPTIDE-1
PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-251
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.61 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-251-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-251-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-255
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.34 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-255-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-255-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-256
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.34 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-256-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-256-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-253
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.61 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-253-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-253-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-257
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.61 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-257-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-257-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-258
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.34 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-258-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-258-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

ITC CC ILLUMINATION FULL COVERAGE CREAM DEEP
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-262
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.914 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-262-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-262-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10.96 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-260-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-260-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-261
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.98 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-261-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-261-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-254
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.34 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-254-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-254-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-259
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.05 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-259-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-259-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11090-252
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.30006 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.34 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM STEARATE (UNII: 776XM7047L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEMON OIL (UNII: I9GRO824LL)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MICA (UNII: V8A1AW0880)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
BABASSU OIL (UNII: 8QSB4M5477)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ORANGE OIL (UNII: AKN3KSD11B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OATMEAL (UNII: 8PI54V663Y)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
STEARETH-20 (UNII: L0Q8IK9E08)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
GIANT AFRICAN SNAIL (UNII: 5A1SK0DCIZ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CHRYSIN (UNII: 3CN01F5ZJ5)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
LIME OIL (UNII: UZH29XGA8G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
HYALURONIC ACID (UNII: S270N0TRQY)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11090-252-01	1 in 1 BOX	08/30/2021
1		32 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:11090-252-02	1 in 1 BOX	08/30/2021
2		75 g 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 final	part352	08/30/2021

Labeler - Beauty Manufacturing Solutions Corp (783200723)

Registrant - Beauty Manufacturing Solutions Corp (783200723)

Name	Address	ID/FEI	Business Operations
Establishment
Beauty Manufacturing Solutions Corp		783200723	manufacture(11090-251, 11090-252, 11090-253, 11090-254, 11090-255, 11090-256, 11090-257, 11090-258, 11090-259, 11090-260, 11090-261, 11090-262)

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Published Date (What is this?)	Version	Files
Feb 17, 2022	2 (current)	download
Sep 20, 2021	1	download

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	NDC
1	11090-251-01
2	11090-251-02
3	11090-252-01
4	11090-252-02
5	11090-253-01
6	11090-253-02
7	11090-254-01
8	11090-254-02
9	11090-255-01
10	11090-255-02
11	11090-256-01
12	11090-256-02
13	11090-257-01
14	11090-257-02
15	11090-258-01
16	11090-258-02
17	11090-259-01
18	11090-259-02
19	11090-260-01
20	11090-260-02
21	11090-261-01
22	11090-261-02
23	11090-262-01
24	11090-262-02

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Number of versions: 2

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