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

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.

Flammable

Do not use near heat, flame, or while smoking.

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

DIMETHICONESILICABIS-PEG-18 METHYL ETHER DIMETHYL SILANEISODODECANETRIMETHYLSILOXYSILICATESD ALCOHOL 40-BTRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMERISOPROPYL MYRISTATEALUMINUM HYDROXIDEPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONESTEARIC ACIDISOSTEARIC ACIDDEXTRIN PALMITATEDISTEARDIMONIUM HECTORITEBIS-BUTYLDIMETHICONE POLYGLYCERYL-3LAUROYL LYSINEPEG/PPG-14/7 DIMETHYL ETHERPCA DIMETHICONEPHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATEPHYTOSTERYL MACADAMIATELECITHINGLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACTSUCROSE TETRASTEARATE TRIACETATEPOLYMETHYLSILSESQUIOXANETALCMETHYL METHACRYLATE CROSSPOLYMERALUMINAPOLYSILICONE-2TRIETHOXYCAPRYLYLSILANEHYDROGEN DIMETHICONETOCOPHEROLBHTETHYLPARABENFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

Other information

• protect this product in this container from excessive heat and direct sun.
• avoid contact with clothing and other textiles-may stain.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Light

SHISEIDO
GINZA TOKYO

Sports BB

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Medium

SHISEIDO
GINZA TOKYO

Sports BB

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Dark

SHISEIDO
GINZA TOKYO

Sports BB

50+
WetForce
Quick Dry

BROAD SPECTRUM
SPF 50+

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SPORTS BB   LIGHT
octinoxate and titanium dioxide lotion

Product 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 FINAL	part352	02/01/2019

SHISEIDO SPORTS BB   MEDIUM
octinoxate and titanium dioxide lotion

Product 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 FINAL	part352	02/01/2019

SHISEIDO SPORTS BB   DARK
octinoxate and titanium dioxide lotion

Product 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 FINAL	part352	02/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-450, 58411-451, 58411-452) , ANALYSIS(58411-450, 58411-451, 58411-452)