Label: SHISEIDO SPORTS HYDROBB COMPACT LIGHT- octinoxate, octocrylene, and titanium dioxide cream
SHISEIDO SPORTS HYDROBB COMPACT MEDIUM- octinoxate, octocrylene, and titanium dioxide cream
SHISEIDO SPORTS HYDROBB COMPACT MEDIUM DARK- octinoxate, octocrylene, and titanium dioxide cream
SHISEIDO SPORTS HYDROBB COMPACT DARK- octinoxate, octocrylene, and titanium dioxide cream
SHISEIDO SPORTS HYDROBB COMPACT VERY DARK- octinoxate, octocrylene, and titanium dioxide cream
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NDC Code(s):
58411-445-30,
58411-446-30,
58411-447-30,
58411-448-30, view more58411-449-30
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 29, 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
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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
CYCLOHEXASILOXANE∙WATER∙DIMETHICONE∙DIPROPYLENE GLYCOL∙ORYZA SATIVA (RICE) BRAN WAX∙SILICA∙BIS-BUTYLDIMETHICONE POLYGLYCERYL-3∙PEG-10 DIMETHICONE∙ALUMINUM HYDROXIDE∙PARAFFIN∙HYDROGEN DIMETHICONE∙GLYCERIN∙PEG/PPG-14/7 DIMETHYL ETHER∙PCA DIMETHICONE∙TRIMETHYLSILOXYSILICATE∙LECITHIN∙GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT∙BIS-PEG-18 METHYL ETHER DIMETHYL SILANE∙POLYSILICONE-2∙ALUMINA∙DISTEARYLDIMONIUM CHLORIDE∙PALMITIC ACID∙POLYMETHYLSILSESQUIOXANE∙DISTEARDIMONIUM HECTORITE∙TALC∙METHYL METHACRYLATE CROSSPOLYMER∙MICROCRYSTALLINE WAX∙TOCOPHEROL∙ISOPROPYL ALCOHOL∙MENTHOXYPROPANEDIOL∙BHT∙STEARIC ACID∙ETHYLPARABEN∙METHYLPARABEN∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Light
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Medium
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Medium Dark
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Dark
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Very Dark
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INGREDIENTS AND APPEARANCE
SHISEIDO SPORTS HYDROBB COMPACT LIGHT
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-445 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 588 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 360 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1608 mg in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) RICE BRAN (UNII: R60QEP13IC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PALMITIC ACID (UNII: 2V16EO95H1) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) 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:58411-445-30 1 in 1 CARTON 02/01/2019 1 12 g 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 final part352 02/01/2019 SHISEIDO SPORTS HYDROBB COMPACT MEDIUM
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-446 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 588 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 360 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1608 mg in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) RICE BRAN (UNII: R60QEP13IC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PALMITIC ACID (UNII: 2V16EO95H1) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) 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:58411-446-30 1 in 1 CARTON 02/01/2019 1 12 g 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 final part352 02/01/2019 SHISEIDO SPORTS HYDROBB COMPACT MEDIUM DARK
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-447 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 588 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 360 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1608 mg in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) RICE BRAN (UNII: R60QEP13IC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PALMITIC ACID (UNII: 2V16EO95H1) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) 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:58411-447-30 1 in 1 CARTON 02/01/2019 1 12 g 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 final part352 02/01/2019 SHISEIDO SPORTS HYDROBB COMPACT DARK
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-448 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 588 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 360 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1608 mg in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) RICE BRAN (UNII: R60QEP13IC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PARAFFIN (UNII: I9O0E3H2ZE) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PALMITIC ACID (UNII: 2V16EO95H1) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) 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:58411-448-30 1 in 1 CARTON 02/01/2019 1 12 g 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 final part352 02/01/2019 SHISEIDO SPORTS HYDROBB COMPACT VERY DARK
octinoxate, octocrylene, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-449 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 588 mg in 12 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 360 mg in 12 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1608 mg in 12 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL (UNII: E107L85C40) RICE BRAN (UNII: R60QEP13IC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) PARAFFIN (UNII: I9O0E3H2ZE) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PALMITIC ACID (UNII: 2V16EO95H1) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TALC (UNII: 7SEV7J4R1U) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ISOPROPYL ALCOHOL (UNII: ND2M416302) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) 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:58411-449-30 1 in 1 CARTON 02/01/2019 1 12 g 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 final part352 02/01/2019 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-445, 58411-446, 58411-447, 58411-448, 58411-449) , ANALYSIS(58411-445, 58411-446, 58411-447, 58411-448, 58411-449)
