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 
Beauty Manufacturing Solutions Corp

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.

----------

ITC CC+ Illumination

Titanium Oxide 9%, Zinc Oxide 6.3%

Purpuse: Sunscreen

Suncreen

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.

For external use only

on damaged or broken skin

if rash occurs

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

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

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

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

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ITC CC ILLUMINATION FULL COVERAGE CREAM FAIR 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-251
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.61 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-251-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-251-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM NEUTRAL MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-255
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.34 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-255-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-255-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-256
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.34 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-256-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-256-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-253
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.61 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-253-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-253-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM MEDIUM TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-257
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.61 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-257-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-257-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM NEUTRAL TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-258
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.34 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-258-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-258-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM DEEP 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-262
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.914 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-262-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-262-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM RICH 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.96 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-260-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-260-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM RICH HONEY 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-261
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.98 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-261-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-261-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM LIGHT MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-254
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.34 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-254-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-254-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-259
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.05 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-259-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-259-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
ITC CC ILLUMINATION FULL COVERAGE CREAM FAIR LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.30006 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.34 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-252-011 in 1 BOX08/30/2021
132 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-252-021 in 1 BOX08/30/2021
275 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2021
Labeler - Beauty Manufacturing Solutions Corp (783200723)
Registrant - Beauty Manufacturing Solutions Corp (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp783200723manufacture(11090-251, 11090-252, 11090-253, 11090-254, 11090-255, 11090-256, 11090-257, 11090-258, 11090-259, 11090-260, 11090-261, 11090-262)

Revised: 2/2022
Document Id: d7d69ce3-902c-5acd-e053-2995a90aaffe
Set id: c611a0b6-81a4-f5c5-e053-2995a90a1c52
Version: 2
Effective Time: 20220212
 
Beauty Manufacturing Solutions Corp