SHISEIDO SPORTS BB LIGHT- octinoxate and titanium dioxide liquid
SHISEIDO SPORTS BB MEDIUM- octinoxate and titanium dioxide liquid
SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide liquid
SHISEIDO AMERICAS CORPORATION

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SHISEIDO SPORTS BB

Drug Facts

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 15.0%	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

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

WATER•DIMETHICONE•TRIMETHYLSILOXYSILICATE•ISODODECANE•METHYL METHACRYLATE CROSSPOLYMER•SD ALCOHOL 40-B•XYLITOL•ISOPROPYL MYRISTATE•ALUMINUM HYDROXIDE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•ALUMINUM DISTEARATE•ISOSTEARIC ACID•DEXTRIN PALMITATE•BIS-BUTYLDIMETHICONE POLYGLYCERYL-3•SERINE•GLYCINE•SODIUM PCA•ASPARTIC ACID•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•DISTEARDIMONIUM HECTORITE•TRISODIUM EDTA•SILICA•ALANINE•POLYMETHYLSILSESQUIOXANE•TALC•ALUMINA•ALCOHOL•SODIUM CITRATE•POLYSILICONE-2•TRIETHOXYCAPRYLYLSILANE•HYDROGEN DIMETHICONE•BUTYLENE GLYCOL•CITRIC ACID•TOCOPHEROL•STEARIC ACID•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•METHYLPARABEN•ETHYLPARABEN•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 - 30 mL Bottle Carton - LIGHT

SHISEIDO

Anti-Aging Suncare

50+
WetForce
BB

Sports BB

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Bottle Carton - LIGHT

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - MEDIUM

SHISEIDO

Anti-Aging Suncare

50+
WetForce
BB

Sports BB

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Bottle Carton - MEDIUM

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - DARK

SHISEIDO

Anti-Aging Suncare

50+
WetForce
BB

Sports BB

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Bottle Carton - DARK

SHISEIDO SPORTS BB LIGHT
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-299
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1727 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5288 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ISODODECANE (UNII: A8289P68Y2)
XYLITOL (UNII: VCQ006KQ1E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ASPARTIC ACID (UNII: 30KYC7MIAI)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALANINE (UNII: OF5P57N2ZX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-299-10	1 in 1 CARTON	02/01/2017	10/31/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/01/2017	10/31/2020

SHISEIDO SPORTS BB MEDIUM
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1727 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5288 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ISODODECANE (UNII: A8289P68Y2)
XYLITOL (UNII: VCQ006KQ1E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ASPARTIC ACID (UNII: 30KYC7MIAI)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALANINE (UNII: OF5P57N2ZX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-300-10	1 in 1 CARTON	02/01/2017	12/31/2021
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/01/2017	12/31/2021

SHISEIDO SPORTS BB DARK
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1727 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5288 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ISODODECANE (UNII: A8289P68Y2)
XYLITOL (UNII: VCQ006KQ1E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ASPARTIC ACID (UNII: 30KYC7MIAI)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALANINE (UNII: OF5P57N2ZX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-301-10	1 in 1 CARTON	02/01/2017	12/31/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/01/2017	12/31/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(58411-299, 58411-300, 58411-301) , analysis(58411-299, 58411-300, 58411-301)

Revised: 10/2023

Document Id: 61f8c243-c27e-4e09-9582-7c75a6bc42a7

Set id: 25fb4b88-deb7-49a2-a474-fb5cd67f71c8

Version: 4

Effective Time: 20231023

SHISEIDO AMERICAS CORPORATION