FDA.reportPublic FDA data

SHISEIDO SPORTS BB

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:31:11

Label at a glance#

ProductSHISEIDO SPORTS BB LIGHT
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure11 sections

Indications and 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

Dosage and administration

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: lim...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
OCTINOXATE 4.9%Sunscreen
TITANIUM DIOXIDE 15.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - Light
Principal Display Panel - 30 mL Container Carton - Light

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Medium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 30 mL Container Carton - Medium

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Dark

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 30 mL Container Carton - Dark

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-452-102023-12-29C16284748780-19d75b9d0-1d0b-f424-e053-dadaa90a57ceSHISEIDO SPORTS BB
58411-452-102020-01-31C16284748780-19d75b9d0-1d0b-f424-e053-dadaa90a57ceSHISEIDO SPORTS BB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-450-10SHISEIDO SPORTS BBLIGHT30 mL in 1 CONTAINERLOTION304
58411-450-10SHISEIDO SPORTS BBLIGHT1 in 1 CARTONLOTION14
58411-451-10SHISEIDO SPORTS BBMEDIUM30 mL in 1 CONTAINERLOTION304
58411-451-10SHISEIDO SPORTS BBMEDIUM1 in 1 CARTONLOTION14
58411-452-10SHISEIDO SPORTS BBDARK30 mL in 1 CONTAINERLOTION304
58411-452-10SHISEIDO SPORTS BBDARK1 in 1 CARTONLOTION14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-45058411-450-10
58411-45158411-451-10
58411-45258411-452-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 96 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
ISODODECANEA8289P68Y2IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
STEARIC ACID4ELV7Z65APIACT
ISOSTEARIC ACIDX33R8U0062IACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
LAUROYL LYSINE113171Q70BIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
PHYTOSTERYL MACADAMIATE233VSF903MIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SUCROSE TETRASTEARATE TRIACETATE1K7LBQ045NIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TALC7SEV7J4R1UIACT
ALUMINUM OXIDELMI26O6933IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ETHYLPARABEN14255EXE39IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
ISODODECANEA8289P68Y2IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
ndc (package): 58411-451-10
ndc (package): 58411-450-10
ndc (package): 58411-452-10
ndc (product): 58411-451
ndc (product): 58411-450
ndc (product): 58411-452
ndc11 (package): 58411045010
ndc11 (package): 58411045110
ndc11 (package): 58411045210
spl id: 47a94a6a-78b4-6604-e063-6394a90a1060
spl set id: 260a3eab-8fe6-4259-8dcc-3706ca1f6881

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.