SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide emulsion

SHISEIDO SPORTS BB DARK by

Drug Labeling and Warnings

SHISEIDO SPORTS BB DARK by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. 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%	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

• apply liberally 15 minutes before sun exposure
• reply
  • after 80 minutes after swimming and 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 un 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

DIMETHICONE▪SILICA▪BIS-PEG-18 METHYL ETHER DIMETHYL SILANE▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪SD ALCOHOL 40-B▪TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER▪ISOPROPYL MYRISTATE▪ALUMINUM HYDROXIDE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪STEARIC ACID▪ISOSTEARIC ACID▪DEXTRIN PALMITATE▪DISTEARDIMONIUM HECTORITE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪LAUROYL LYSINE▪PEG/PPG-14/7 DIMETHYL ETHER▪PCA DIMETHICONE▪PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE▪PHYTOSTERYL MACADAMIATE▪LECITHIN▪GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT▪SUCROSE TETRASTEARATE TRIACETATE▪POLYMETHYLSILSESQUIOXANE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪ALUMINA▪POLYSILICONE-2▪TRIETHOXYCAPRYLYLSILANE▪HYDROGEN DIMETHICONE▪TOCOPHEROL▪BHT▪ETHYLPARABEN▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪MICA▪

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 Bottle Carton

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 DARK 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-536
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.81545 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5575 g  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)
ALCOHOL (UNII: 3K9958V90M)
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)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
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: 58411-536-10	1 in 1 CARTON	03/01/2019
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 FINAL	part352	03/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)