Label: SHISEIDO SPORTS BB LIGHT- octinoxate and titanium dioxide lotion
SHISEIDO SPORTS BB MEDIUM- octinoxate and titanium dioxide lotion
SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide lotion
- NDC Code(s): 58411-450-10, 58411-451-10, 58411-452-10
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 23, 2024
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
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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
DIMETHICONE•SILICA•BIS-PEG-18 METHYL ETHER DIMETHYL SILANE•ISODODECANE•TRIMETHYLSILOXYSILICATE•SD ALCOHOL 40-B•TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER•ISOPROPYL MYRISTATE•ALUMINUM HYDROXIDE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•STEARIC ACID•ISOSTEARIC ACID•DEXTRIN PALMITATE•DISTEARDIMONIUM HECTORITE•BIS-BUTYLDIMETHICONE POLYGLYCERYL-3•LAUROYL LYSINE•PEG/PPG-14/7 DIMETHYL ETHER•PCA DIMETHICONE•PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE•PHYTOSTERYL MACADAMIATE•LECITHIN•GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT•SUCROSE TETRASTEARATE TRIACETATE•POLYMETHYLSILSESQUIOXANE•TALC•METHYL METHACRYLATE CROSSPOLYMER•ALUMINA•POLYSILICONE-2•TRIETHOXYCAPRYLYLSILANE•HYDROGEN DIMETHICONE•TOCOPHEROL•BHT•ETHYLPARABEN•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Light
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Medium
- PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Dark
-
INGREDIENTS AND APPEARANCE
SHISEIDO SPORTS BB LIGHT
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1815 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5558 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) STEARIC ACID (UNII: 4ELV7Z65AP) ISOSTEARIC ACID (UNII: X33R8U0062) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAUROYL LYSINE (UNII: 113171Q70B) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ETHYLPARABEN (UNII: 14255EXE39) 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:58411-450-10 1 in 1 CARTON 02/01/2019 1 30 mL in 1 CONTAINER; 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 02/01/2019 SHISEIDO SPORTS BB MEDIUM
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-451 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1815 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5558 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) STEARIC ACID (UNII: 4ELV7Z65AP) ISOSTEARIC ACID (UNII: X33R8U0062) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAUROYL LYSINE (UNII: 113171Q70B) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ETHYLPARABEN (UNII: 14255EXE39) 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:58411-451-10 1 in 1 CARTON 02/01/2019 1 30 mL in 1 CONTAINER; 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 02/01/2019 SHISEIDO SPORTS BB DARK
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-452 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1815 mg in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5558 mg in 30 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ISODODECANE (UNII: A8289P68Y2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) STEARIC ACID (UNII: 4ELV7Z65AP) ISOSTEARIC ACID (UNII: X33R8U0062) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAUROYL LYSINE (UNII: 113171Q70B) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ETHYLPARABEN (UNII: 14255EXE39) 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:58411-452-10 1 in 1 CARTON 02/01/2019 1 30 mL in 1 CONTAINER; 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 02/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations Shiseido America Inc. 782677132 ANALYSIS(58411-450, 58411-451, 58411-452) , MANUFACTURE(58411-450, 58411-451, 58411-452)