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 
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+ Full Coverage Cream

Titanium dioxide 9.0%

Zinc oxide 6.3%%

sunscreen

For external use only

keep out of eyes. Rinse with water to remove

rash occurs

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

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

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

Call 800-620-3950

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

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ITC CC FULL COVERAGE CREAM NEUTRAL MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-108-011 in 1 CARTON03/14/2018
112 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-108-031 in 1 CARTON03/14/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-108-021 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM NEUTRAL TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-110-011 in 1 CARTON03/14/2018
112 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-110-031 in 1 CARTON03/14/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-110-021 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM FAIR LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-104-011 in 1 CARTON03/14/2018
112 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-104-031 in 1 CARTON03/14/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-104-021 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM LIGHT 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-105-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-105-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-105-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-105-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-107-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-107-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-107-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-107-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM MEDIUM TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-109-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-109-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-109-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-109-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM TAN 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-111-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-111-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-111-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-111-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM RICH HONEY 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-113-011 in 1 CARTON03/14/2018
112 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-113-031 in 1 CARTON03/14/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-113-021 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM FAIR 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-103-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-103-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-103-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-103-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM LIGHT MEDIUM 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-106-011 in 1 CARTON03/14/2018
112 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-106-031 in 1 CARTON03/14/2018
275 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-106-021 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
ITC CC FULL COVERAGE CREAM RICH 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-112-011 in 1 CARTON03/14/2018
14 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11090-112-021 in 1 CARTON03/14/2018
212 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:11090-112-031 in 1 CARTON03/14/2018
332 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:11090-112-041 in 1 CARTON03/14/2018
475 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/14/2018
Labeler - Beauty Manufacturing Solutions Corp. (783200723)
Registrant - Beauty Manufacturing Solutions Corp. (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(11090-103, 11090-104, 11090-105, 11090-106, 11090-107, 11090-108, 11090-109, 11090-110, 11090-111, 11090-112, 11090-113)

Revised: 2/2022
Document Id: d7c0fce8-715d-4a93-e053-2a95a90a86c6
Set id: d7c0fce8-715c-4a93-e053-2a95a90a86c6
Version: 1
Effective Time: 20220211
 
Beauty Manufacturing Solutions Corp.