Label: SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY- octinoxate, octocrylene, and titanium dioxide powder
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NDC Code(s):
58411-121-30,
58411-122-30,
58411-123-30,
58411-124-30, view more58411-125-30, 58411-126-30, 58411-127-30, 58411-128-30, 58411-129-30
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 25, 2026
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
-
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
-
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
SYNTHETIC FLUORPHLOGOPITE,DIMETHICONE,SILICA,NYLON-12,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,PETROLATUM,METHICONE,TRIETHYLHEXANOIN,PEG/PPG-14/7 DIMETHYL ETHER,TOCOPHERYL ACETATE,SAXIFRAGA SARMENTOSA EXTRACT,SODIUM HYALURONATE,SOPHORA ANGUSTIFOLIA ROOT EXTRACT,SORBITAN SESQUIISOSTEARATE,HYDROGEN DIMETHICONE,ALUMINUM HYDROXIDE,WATER,POLYSILICONE-2,ALCOHOL,SODIUM MAGNESIUM SILICATE,HYDRATED SILICA,TRIETHOXYCAPRYLYLSILANE,ALUMINUM DISTEARATE,BUTYLENE GLYCOL,GLYCERIN,TOCOPHEROL,BHT,DISTEARYLDIMONIUM CHLORIDE,SYZYGIUM JAMBOS LEAF EXTRACT,TIN OXIDE,CHLORPHENESIN,FRAGRANCE,MICA,TITANIUM DIOXIDE,IRON OXIDES,ZINC OXIDE,
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Fair Ivory
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Beige
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ivory
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ochre
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Beige
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ivory
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ochre
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Beige
- PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Ivory
-
INGREDIENTS AND APPEARANCE
SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-122-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-121-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-123-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-124-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-125-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-126 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-126-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-127-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-128-30 1 in 1 CARTON 02/01/2014 05/01/2024 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 05/01/2024 SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY
octinoxate, octocrylene, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 888 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 600 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1416 mg in 12 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NYLON-12 (UNII: 446U8J075B) PETROLATUM (UNII: 4T6H12BN9U) METHICONE (20 CST) (UNII: 6777U11MKT) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) CHLORPHENESIN (UNII: I670DAL4SZ) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-129-30 1 in 1 CARTON 02/01/2014 1 12 g in 1 TRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 analysis(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129) , manufacture(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129)
