SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide emulsion 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SHISEIDO SPORTS BB DARK

Drug Facts

Active ingredientsPurpose
OCTINOXATE 4.9%Sunscreen
TITANIUM DIOXIDE 15%Sunscreen

Uses

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

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

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.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
SHISEIDO SPORTS BB DARK 
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-536
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.81545 g  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5575 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-536-101 in 1 CARTON03/01/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/01/2019
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 4/2020
Document Id: f72bcc36-3355-4d3f-8223-700fed362dec
Set id: f4fc4b6a-9507-496e-9ecb-8400055ecf2d
Version: 1
Effective Time: 20200416
 
SHISEIDO AMERICAS CORPORATION