Drug Facts

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
TITANIUM DIOXIDE 13.4%	Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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
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

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

protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Light

SHISEIDO
GINZA TOKYO

Sports HydroBB Compact
(Refill)

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Container Carton - Light

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Medium

SHISEIDO
GINZA TOKYO

Sports HydroBB Compact
(Refill)

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Medium Dark

SHISEIDO
GINZA TOKYO

Sports HydroBB Compact
(Refill)

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Container Carton - Medium Dark

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Dark

SHISEIDO
GINZA TOKYO

Sports HydroBB Compact
(Refill)

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Container Carton - Dark

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - Very Dark

SHISEIDO
GINZA TOKYO

Sports HydroBB Compact
(Refill)

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Container Carton - Very Dark

SHISEIDO SPORTS HYDROBB COMPACT LIGHT
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-445
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

SHISEIDO SPORTS HYDROBB COMPACT MEDIUM
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-446
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

SHISEIDO SPORTS HYDROBB COMPACT MEDIUM DARK
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-447
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

SHISEIDO SPORTS HYDROBB COMPACT DARK
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-448
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

SHISEIDO SPORTS HYDROBB COMPACT VERY DARK
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-449
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
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)