Label: SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY- octinoxate and titanium dioxide stick
SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE- octinoxate and titanium dioxide stick
SHISEIDO UV PROTECTIVE FOUNDATION BEIGE- octinoxate and titanium dioxide stick
SHISEIDO UV PROTECTIVE FOUNDATION OCHRE- octinoxate and titanium dioxide stick
- NDC Code(s): 58411-137-20, 58411-138-20, 58411-139-20, 58411-140-20
- 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 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
-
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
-
Inactive Ingredients
MINERAL OIL, POLYMETHYL METHACRYLATE, DIMETHICONE, KAOLIN, TRIETHYLHEXANOIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PEG/PPG-14/7 DIMETHYL ETHER, SAXIFRAGA SARMENTOSA EXTRACT, SODIUM HYALURONATE, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, WATER, ALUMINA, ALCOHOL, SODIUM MAGNESIUM SILICATE, HYDRATED SILICA, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TIN OXIDE, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, MICA,
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Fair Ivory
- PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Fair Ochre
- PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Beige
- PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Ochre
-
INGREDIENTS AND APPEARANCE
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY
octinoxate and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 261 mg in 9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 648 mg in 9 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) CARNAUBA WAX (UNII: R12CBM0EIZ) METHICONE (20 CST) (UNII: 6777U11MKT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) 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:58411-137-20 1 in 1 CARTON 02/01/2014 1 9 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE
octinoxate and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 261 mg in 9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 648 mg in 9 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) CARNAUBA WAX (UNII: R12CBM0EIZ) METHICONE (20 CST) (UNII: 6777U11MKT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) 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:58411-138-20 1 in 1 CARTON 02/01/2014 1 9 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION BEIGE
octinoxate and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 261 mg in 9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 648 mg in 9 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) CARNAUBA WAX (UNII: R12CBM0EIZ) METHICONE (20 CST) (UNII: 6777U11MKT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) 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:58411-139-20 1 in 1 CARTON 02/01/2014 1 9 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 02/01/2014 SHISEIDO UV PROTECTIVE FOUNDATION OCHRE
octinoxate and titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 261 mg in 9 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 648 mg in 9 g Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) MINERAL OIL (UNII: T5L8T28FGP) DIMETHICONE (UNII: 92RU3N3Y1O) KAOLIN (UNII: 24H4NWX5CO) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) CARNAUBA WAX (UNII: R12CBM0EIZ) METHICONE (20 CST) (UNII: 6777U11MKT) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) ALCOHOL (UNII: 3K9958V90M) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) STANNIC OXIDE (UNII: KM7N50LOS6) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-140-20 1 in 1 CARTON 02/01/2014 1 9 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 02/01/2014 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-137, 58411-138, 58411-139, 58411-140) , analysis(58411-137, 58411-138, 58411-139, 58411-140)
