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 SPORTS BB by

Drug Labeling and Warnings

SHISEIDO SPORTS BB by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

WATERDIMETHICONETRIMETHYLSILOXYSILICATEISODODECANEMETHYL METHACRYLATE CROSSPOLYMERSD ALCOHOL 40-BXYLITOLISOPROPYL MYRISTATEALUMINUM HYDROXIDEPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEALUMINUM DISTEARATEISOSTEARIC ACIDDEXTRIN PALMITATEBIS-BUTYLDIMETHICONE POLYGLYCERYL-3SERINEGLYCINESODIUM PCAASPARTIC ACIDPEG/PPG-14/7 DIMETHYL ETHERSAXIFRAGA SARMENTOSA EXTRACTSOPHORA ANGUSTIFOLIA ROOT EXTRACTDISTEARDIMONIUM HECTORITETRISODIUM EDTASILICAALANINEPOLYMETHYLSILSESQUIOXANETALCALUMINAALCOHOLSODIUM CITRATEPOLYSILICONE-2TRIETHOXYCAPRYLYLSILANEHYDROGEN DIMETHICONEBUTYLENE GLYCOLCITRIC ACIDTOCOPHEROLSTEARIC ACIDBHTSYZYGIUM JAMBOS LEAF EXTRACTMETHYLPARABENETHYLPARABENFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

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

SHI SEIDO

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

SHI SEIDO

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

SHI SEIDO

Anti-Aging Suncare

50+
WetForce
BB

Sports BB

BROAD SPECTRUM
SPF 50+

WATER RESISTANT (80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

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