FDA.reportPublic FDA data

SHISEIDO SPORTS BB

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:42:34

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

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,...

Storage and handling

protect this product in this container from excessive heat and direct sun.

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 use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

WATER•DIMETHICONE•TRIMETHYLSILOXYSILICATE•ISODODECANE•METHYL METHACRYLATE CROSSPOLYMER•SD ALCOHOL 40-B•XYLITOL•ISOPROPYL MYRISTATE•ALUMINUM HYDROXIDE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•ALUMINUM DISTEARATE•ISOSTEARIC ACID•DEXTRIN PALMITATE•BIS-BUTYLDIMETHICONE POLYGLYCERYL-3•SERINE•GLYCINE•SODIUM PCA•ASPARTIC ACID•PEG/PPG-14/7 DIMETHYL ETHER•SAXIFRAGA SARMENTOSA EXTRACT•SOPHORA ANGUSTIFOLIA ROOT EXTRACT•DISTEARDIMONIUM HECTORITE•TRISODIUM EDTA•SILICA•ALANINE•POLYMETHYLSILSESQUIOXANE•TALC•ALUMINA•ALCOHOL•SODIUM CITRATE•POLYSILICONE-2•TRIETHOXYCAPRYLYLSILANE•HYDROGEN DIMETHICONE•BUTYLENE GLYCOL•CITRIC ACID•TOCOPHEROL•STEARIC ACID•BHT•SYZYGIUM JAMBOS LEAF EXTRACT•METHYLPARABEN•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.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - LIGHT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - LIGHT
Principal Display Panel - 30 mL Bottle Carton - LIGHT

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - MEDIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 30 mL Bottle Carton - MEDIUM

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - DARK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 30 mL Bottle Carton - DARK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-299-102023-12-21C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB
58411-300-102023-12-21C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB
58411-301-102023-12-21C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB
58411-299-102021-01-29C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB
58411-300-102021-01-29C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB
58411-301-102021-01-29C16284748780-1ba0f9c33-385e-a910-e053-dadaa90a0b85SHISEIDO SPORTS BB

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-29958411-299-10
58411-30058411-300-10
58411-30158411-301-10

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 126 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
ISODODECANEA8289P68Y2IACT
XYLITOLVCQ006KQ1EIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
ISOSTEARIC ACIDX33R8U0062IACT
SERINE452VLY9402IACT
GLYCINETE7660XO1CIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ASPARTIC ACID30KYC7MIAIIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
EDETATE TRISODIUM420IP921MBIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALANINEOF5P57N2ZXIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TALC7SEV7J4R1UIACT
ALUMINUM OXIDELMI26O6933IACT
ALCOHOL3K9958V90MIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
STEARIC ACID4ELV7Z65APIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SYZYGIUM JAMBOS LEAF407Z4W5LFFIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT

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
61f8c243-c27e-4e09-9582-7c75a6bc42a725fb4b88-deb7-49a2-a474-fb5cd67f71c82023-10-23WarningsExact identifier
spl set id: 25fb4b88-deb7-49a2-a474-fb5cd67f71c8

Reported adverse events (FAERS/openFDA)#

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