Label: SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY- octinoxate, octocrylene, and titanium dioxide powder
SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE- 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
-
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
- 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 13, 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
-
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) 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 not final part352 02/01/2014 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 not final part352 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 not final part352 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 not final part352 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 not final part352 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 not final part352 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 not final part352 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 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 not final part352 02/01/2014 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 not final part352 02/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129) , analysis(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129)
