Label: SHISEIDO UV PROTECTIVE FOUNDATION LIGHT BEIGE- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION LIGHT IVORY- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION LIGHT OCHRE- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM BEIGE- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM IVORY- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION DARK BEIGE- octinoxate and titanium dioxide cream
SHISEIDO UV PROTECTIVE FOUNDATION DARK IVORY- octinoxate and titanium dioxide cream
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NDC Code(s):
58411-130-10,
58411-131-10,
58411-132-10,
58411-133-10, view more58411-134-10, 58411-135-10, 58411-136-10
- 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 December 19, 2018
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 INGREDIENT
-
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
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
-
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
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Inactive Ingredients
WATER, DIMETHICONE, TRIMETHYLSILOXYSILICATE, ISODODECANE, POLYMETHYL METHACRYLATE, CYCLOMETHICONE, SD ALCOHOL 40-B, PEG/PPG-19/19 DIMETHICONE, HYDROGENATED POLYISOBUTENE, BIS-BUTYLDIMETHICONE POLYGLYCERYL-3, PEG/PPG-14/7 DIMETHYL ETHER, SAXIFRAGA SARMENTOSA EXTRACT, SODIUM HYALURONATE, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, ALUMINA, ISOSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, SILICA, POLYSILICONE-2, ALCOHOL, SODIUM MAGNESIUM SILICATE, HYDRATED SILICA, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, DISTEARYLDIMONIUM CHLORIDE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, HYDROGEN DIMETHICONE, TIN OXIDE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, MICA,
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Light Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Light Ivory
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Light Ochre
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Medium Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Medium Ivory
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Dark Beige
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Dark Ivory
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INGREDIENTS AND APPEARANCE
SHISEIDO UV PROTECTIVE FOUNDATION LIGHT BEIGE
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-130-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION LIGHT IVORY
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-131-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION LIGHT OCHRE
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-132-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM BEIGE
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-133-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM IVORY
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-134-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION DARK BEIGE
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-135-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION DARK IVORY
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-136 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 644 mg in 33.9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2814 mg in 33.9 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ALUMINUM OXIDE (UNII: LMI26O6933) ISOSTEARIC ACID (UNII: X33R8U0062) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) EDETATE TRISODIUM (UNII: 420IP921MB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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:58411-136-10 1 in 1 CARTON 02/01/2014 1 33.9 g in 1 BOTTLE; 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 02/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-130, 58411-131, 58411-132, 58411-133, 58411-134, 58411-135, 58411-136) , analysis(58411-130, 58411-131, 58411-132, 58411-133, 58411-134, 58411-135, 58411-136)
