FDA.reportPublic FDA data

SHISEIDO SPORTS BB

Product NDC
58411-451
11-digit product format
584110451
Labeler code
58411
Product ID
58411-451_47a94a6a-78b4-6604-e063-6394a90a1060
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-01
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1815; 5558 mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SHISEIDO SPORTS BB
Brand name suffix
MEDIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1815 mg/30mL
TITANIUM DIOXIDE5558 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
260a3eab-8fe6-4259-8dcc-3706ca1f6881Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-451-10SHISEIDO SPORTS BBMEDIUM30 mL in 1 CONTAINERLOTION304
58411-451-10SHISEIDO SPORTS BBMEDIUM1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-451SHISEIDO 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 AMERICAS CORPORATION]3Current NDC, Legacy NDC, 2 package rows20241228_260a3eab-8fe6-4259-8dcc-3706ca1f6881.zip

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 52 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris UV Expert Aquagel Defense 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc500e58f-38b0-454e-8923-912844276b172026-03-20WarningsExact identifier
application number: M020
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
application number: M020
SOJO sunscreenZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d44efb6-abc5-c346-e063-6394a90a60232026-03-19WarningsExact identifier
application number: M020
VRC Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d588fbe-e61a-2264-e063-6394a90aa0602026-03-19WarningsExact identifier
application number: M020
SOjO Lip balm SPF15ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4d5ed865-fff2-ee44-e063-6294a90a67e22026-03-19WarningsExact identifier
application number: M020
ActivDerm Radiant Shield Broad Spectrum SPF 40ZINC OXIDEACTIVDERM LLC4d6307f1-bab6-5f44-e063-6294a90a8e362026-03-19WarningsExact identifier
application number: M020
Mad Robbit DEFEND SPF30SUNSCREENMAD RABBIT TATTOO, INC.bf853d54-ecd9-40cc-9f10-cb546bfb89332026-03-19WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREENZINC OXIDECLIO COSMETICS Co., Ltd.c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e2026-03-18WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLEZINC OXIDECOSMAX USA4d318f51-1a43-44d5-e063-6394a90a49702026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVEZINC OXIDECOSMAX USA4d319110-e6a4-1ad3-e063-6394a90aa99c2026-03-17WarningsExact identifier
application number: M020
TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORALZINC OXIDECOSMAX USA4d31b201-9d6a-730a-e063-6394a90a67002026-03-17WarningsExact identifier
application number: M020
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
application number: M020
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
application number: M020
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-451-10584110451101 CONTAINER in 1 CARTON (58411-451-10) / 30 mL in 1 CONTAINER1 container2019-02-010000-00-00NoNoCurrent