Label: CLE DE PEAU BEAUTE CONCEALER N 1- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 2- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 3- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 4- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 5- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 7- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 8- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 9- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 10- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 11- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 12- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 13- titanium dioxide stick
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NDC Code(s):
58411-658-20,
58411-659-20,
58411-660-20,
58411-661-20, view more58411-662-20, 58411-663-20, 58411-664-20, 58411-665-20, 58411-666-20, 58411-667-20, 58411-668-20, 58411-669-20
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive Ingredients
HYDROGENATED POLYDECENE•DIMETHICONE•KAOLIN•NEOPENTYL GLYCOL DIHEPTANOATE•DIPHENYLSILOXY PHENYL TRIMETHICONE•LITHIUM MAGNESIUM SODIUM SILICATE•POLYETHYLENE•PARAFFIN•COPERNICIA CERIFERA (CARNAUBA) WAX•SORBITAN SESQUIISOSTEARATE•MICROCRYSTALLINE WAX•GLYCERIN•BARIUM SULFATE•PHYTOSTERYL MACADAMIATE•ARGANIA SPINOSA KERNEL OIL•TOCOPHERYL ACETATE•SODIUM ACETYLATED HYALURONATE•ROSA ROXBURGHII FRUIT EXTRACT•ZINGIBER AROMATICUS EXTRACT•ALUMINUM HYDROXIDE•DIPROPYLENE GLYCOL•PEG-10 DIMETHICONE•WATER•STEARIC ACID•ALCOHOL•BUTYLENE GLYCOL•TOCOPHEROL•SIMETHICONE•BHT•CHLORPHENESIN•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 1
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 2
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- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 8
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 9
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 10
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 11
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 12
- PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 13
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE CONCEALER N 1
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-658 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-658-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 2
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-659 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-659-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 3
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-660 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-660-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 4
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-661 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-661-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 5
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-662 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-662-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 7
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-663 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-663-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 8
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-664 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-664-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 9
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-665 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-665-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 10
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-666 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-666-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 11
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-667 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-667-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 12
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-668 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-668-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 CLE DE PEAU BEAUTE CONCEALER N 13
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-669 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 80 mg in 5 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) LAPONITE (UNII: D703131383) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PARAFFIN (UNII: I9O0E3H2ZE) CARNAUBA WAX (UNII: R12CBM0EIZ) SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GLYCERIN (UNII: PDC6A3C0OX) BARIUM SULFATE (UNII: 25BB7EKE2E) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) ARGAN OIL (UNII: 4V59G5UW9X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALCOHOL (UNII: 3K9958V90M) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-669-20 1 in 1 CARTON 01/01/2022 1 5 g in 1 CARTRIDGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2022 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
