Label: 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
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NDC Code(s):
11090-251-01,
11090-251-02,
11090-252-01,
11090-252-02, view more11090-253-01, 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
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 healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
-
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
- PRINCIPAL DISPLAY PANEL
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- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ITC CC ILLUMINATION FULL COVERAGE CREAM FAIR
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM NEUTRAL MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-255 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-256 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-253 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM MEDIUM TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-257 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM NEUTRAL TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM DEEP
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM RICH
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM RICH HONEY
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-261 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM LIGHT MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-254 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM TAN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-259 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 ITC CC ILLUMINATION FULL COVERAGE CREAM FAIR LIGHT
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11090-252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/30/2021 Labeler - Beauty Manufacturing Solutions Corp (783200723) Registrant - Beauty Manufacturing Solutions Corp (783200723) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp 783200723 manufacture(11090-251, 11090-252, 11090-253, 11090-254, 11090-255, 11090-256, 11090-257, 11090-258, 11090-259, 11090-260, 11090-261, 11090-262)