FDA.reportPublic FDA data

SHISEIDO THE MAKEUP FOUNDATION

Product NDC
58411-461
11-digit product format
584110461
Labeler code
58411
Product ID
58411-461_47abe7b4-317b-901b-e063-6394a90a63f2
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
TITANIUM DIOXIDE
Active strength
400 mg/10g
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 THE MAKEUP FOUNDATION
Brand name suffix
B20
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE400 mg/10g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c024fe9-2983-4857-a55a-13406158e3a9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-461-20SHISEIDO THE MAKEUP FOUNDATIONB2010 g in 1 CARTRIDGESTICK104
58411-461-20SHISEIDO THE MAKEUP FOUNDATIONB201 in 1 CARTONSTICK14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-461SHISEIDO THE MAKEUP FOUNDATION I20 (TITANIUM DIOXIDE) STICK SHISEIDO THE MAKEUP FOUNDATION I40 (TITANIUM DIOXIDE) STICK SHISEIDO THE MAKEUP FOUNDATION I60 (TITANIUM DIOXIDE) STICK SHISEIDO THE MAKEUP FOUNDATION B20 (TITANIUM DIOXIDE) STICK SHISEIDO THE MAKEUP FOUNDATION B40 (TITANIUM DIOXIDE) STICK SHISEIDO THE MAKEUP FOUNDATION B60 (TITANIUM DIOXIDE) STICK [SHISEIDO AMERICAS CORPORATION]3Current NDC, Legacy NDC, 2 package rows20241228_3c024fe9-2983-4857-a55a-13406158e3a9.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 211 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarins157cb8ca-1a36-41fb-be9e-b157b146dc4d2025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50 SportAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutionse25e4f76-8311-491b-e053-2a95a90a4fc82025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260b901-5918-48df-e053-2a95a90a68c32025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e25cf8e4-93cd-f5f6-e053-2995a90a45452025-05-06WarningsExact identifier
application number: M020
Mango Bay SPF 30 GallonAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEInspec Solutions LLC.e260c1bc-8b79-abc7-e053-2a95a90ae4d22025-05-06WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Pink StrawberryZINC OXIDEKoco Life LLC347e665f-cb59-ab04-e063-6394a90ad0a62025-05-06WarningsExact identifier
application number: M020
Saucd Toasted Golden Tanning SPF 15 CaramelAVOBENZONE, OCTISALATE, HOMOSALATESAUCD GENERAL TRADING COMPANYe10d41cd-e03e-401c-9024-263350b3ec2a2025-05-05WarningsExact identifier
application number: M020
Visor Clear Body Mist Hydrating Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLCb2d7639c-cbfb-4127-8ee4-7355e0d021e12025-05-05WarningsExact identifier
application number: M020
Jacket Ultimate Performance Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSd4d82c41-01da-40af-a22c-d4d57af7a2f22025-05-05WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Butter Stick SPF 50ZINC OXIDEElemental Herbs, Inc.114c6ac8-b133-cd16-e063-6294a90ac4f92025-05-05WarningsExact identifier
application number: M020
All Good kids mineral sunscreen butter stick SPF 50ZINC OXIDEElemental Herbs, Inc.feb94fd7-6727-6fb1-e053-6394a90a2af12025-05-05WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
application number: M020
EVERY DAY MINERAL SUN SCREEN SPF 45ZINC OXIDEStream2Sea, LLC7ec4954f-7d60-405b-8bff-cb602fc44a4e2025-05-04WarningsExact identifier
application number: M020
ABIB QUICK AND AIRY SUNSTICK DUO SETHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.34292261-4d05-e07d-e063-6294a90a47412025-05-02WarningsExact identifier
application number: M020
LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREENZINC OXIDELion Pose Inc.341b90b4-82ae-e8c6-e063-6394a90aeefd2025-05-01WarningsExact identifier
application number: M020
LAPCOS DAILY SUNSCREEN SPF 50SUNSCREENLAP USA, INC.337c3528-5739-6b4a-e063-6294a90a3cb42025-05-01WarningsExact identifier
application number: M020
Hiya Kids SPF 40 Mineral SunscrenZINC OXIDEHiya Health Products LLC33119ec6-2cd8-8978-e063-6394a90afd972025-05-01WarningsExact identifier
application number: M020
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLCce93b371-26ab-4493-98e0-98234c3a9ba62025-05-01WarningsExact identifier
application number: M020
Winter Rescue KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.24356548-348d-2cd2-e063-6294a90ab3522025-04-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-461-20584110461201 CARTRIDGE in 1 CARTON (58411-461-20) / 10 g in 1 CARTRIDGE1 cartridge2018-01-010000-00-00NoNoCurrent