Label: SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1- ensulizole, octinoxate, and titanium dioxide cream
SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2- ensulizole, octinoxate, and titanium dioxide cream
SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3- ensulizole, octinoxate, and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52686-339-60, 52686-340-60, 52686-341-60 - Packager: SHISEIDO AMERICA INC.
- 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 20, 2019
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
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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 40 minutes of swimming or sweating
- immediately after towel drying
- 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
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Inactive Ingredients
WATER, DIMETHICONE, SD ALCOHOL 40-B, PENTAERYTHRITYL TETRAETHYLHEXANOATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, GLYCERIN, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROGENATED POLYDECENE, TRIMETHYLSILOXYSILICATE, SILICA, XYLITOL, PEG-6, PEG-32, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SAXIFRAGA SARMENTOSA EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, SODIUM PCA, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, PPG-17, ALUMINUM HYDROXIDE, AMINOMETHYL PROPANOL, ALUMINUM DISTEARATE, ISOSTEARIC ACID, STEARIC ACID, TRISODIUM EDTA, POLYMETHYLSILSESQUIOXANE, TALC, BUTYLENE GLYCOL, ALCOHOL, ALUMINA, POLYSILICONE-2, TRIETHOXYCAPRYLYLSILANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE,
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
- PRINCIPAL DISPLAY PANEL - 30mL Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 656 mg in 32.79 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2426 mg in 32.79 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2361 mg in 32.79 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) THIOTAURINE (UNII: NQZ2D7AO62) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) PPG-17 (UNII: OV0Q322E0U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ISOSTEARIC ACID (UNII: X33R8U0062) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE TRISODIUM (UNII: 420IP921MB) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-339-60 1 in 1 CARTON 03/01/2013 1 32.79 g in 1 TUBE; 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 03/01/2013 SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-340 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 656 mg in 32.79 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2426 mg in 32.79 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2361 mg in 32.79 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) THIOTAURINE (UNII: NQZ2D7AO62) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) PPG-17 (UNII: OV0Q322E0U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ISOSTEARIC ACID (UNII: X33R8U0062) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE TRISODIUM (UNII: 420IP921MB) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-340-60 1 in 1 CARTON 03/01/2013 1 32.79 g in 1 TUBE; 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 03/01/2013 SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-341 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 656 mg in 32.79 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2426 mg in 32.79 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2361 mg in 32.79 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) THIOTAURINE (UNII: NQZ2D7AO62) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) ONONIS SPINOSA ROOT (UNII: FD2FMC53M1) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) PPG-17 (UNII: OV0Q322E0U) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI) ISOSTEARIC ACID (UNII: X33R8U0062) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE TRISODIUM (UNII: 420IP921MB) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALCOHOL (UNII: 3K9958V90M) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52686-341-60 1 in 1 CARTON 03/01/2013 1 32.79 g in 1 TUBE; 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 03/01/2013 Labeler - SHISEIDO AMERICA INC. (782677132) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-339, 52686-340, 52686-341) , ANALYSIS(52686-339, 52686-340, 52686-341)
