SHISEIDO PERFECT HYDRATING BB MEDIUM- ensulizole, octinoxate, and titanium dioxide cream SHISEIDO PERFECT HYDRATING BB DARK- ensulizole, octinoxate, and titanium dioxide cream SHISEIDO PERFECT HYDRATING BB LIGHT- ensulizole, octinoxate, and titanium dioxide cream
SHISEIDO PERFECT HYDRATING BB by
Drug Labeling and Warnings
SHISEIDO PERFECT HYDRATING BB by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- 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
- use a water resistant sunscreen if swimming or sweating
- reapply 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?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Dark
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Light
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INGREDIENTS AND APPEARANCE
SHISEIDO PERFECT HYDRATING BB MEDIUM
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 52686-342 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: 52686-342-60 1 in 1 CARTON 1 32.79 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2013 SHISEIDO PERFECT HYDRATING BB DARK
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 52686-343 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: 52686-343-60 1 in 1 CARTON 1 32.79 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/01/2013 SHISEIDO PERFECT HYDRATING BB LIGHT
ensulizole, octinoxate, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 52686-344 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) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 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: 52686-344-60 1 in 1 CARTON 1 32.79 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/01/2014 Labeler - SHISEIDO AMERICA INC. (782677132) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-342, 52686-343, 52686-344) , ANALYSIS(52686-342, 52686-343, 52686-344) Establishment Name Address ID/FEI Business Operations Davlyn Industries Inc 624436254 MANUFACTURE(52686-342, 52686-343, 52686-344)
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