FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR MINERAL

Product NDC
58411-903
11-digit product format
584110903
Labeler code
58411
Product ID
58411-903_4b83c117-3563-32ac-e063-6394a90a4836
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
9.44; 9.77 g/150mL; g/150mL
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 ULTIMATE SUN PROTECTOR MINERAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE9.44 g/150mL
ZINC OXIDE9.77 g/150mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e31eee8-6532-47ea-99fc-22418791804bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-903-40SHISEIDO ULTIMATE SUN PROTECTOR MINERAL150 mL in 1 CONTAINERLOTION1504
58411-903-40SHISEIDO ULTIMATE SUN PROTECTOR MINERAL1 in 1 CARTONLOTION14
58411-903-41SHISEIDO ULTIMATE SUN PROTECTOR MINERAL1 in 1 CARTONLOTION14
58411-903-41SHISEIDO ULTIMATE SUN PROTECTOR MINERAL50 mL in 1 CONTAINERLOTION504

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 122 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Mineral Zinc Oxide SPF 40ZINC OXIDESpalina LLC.35aa74c5-1bb3-9814-e063-6294a90a69992025-12-15Exact identifier
application number: M020
Mineral Tinted SPF40 with ceramidesZINC OXIDESpalina LLC.35ac3bd1-a4c1-5078-e063-6394a90afdc82025-12-15Exact identifier
application number: M020
Suns Out Funs OutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC46040acf-512e-c867-e063-6294a90ac2202025-12-15WarningsExact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
application number: M020
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
application number: M020
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
application number: M020
20Percent Zinc Total ProtectionZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bcaee1-001b-82da-e063-6394a90a4a0f2025-12-15Exact identifier
application number: M020
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
application number: M020
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
application number: M020
Protection E And C Lightly TintedZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bce44e-d9f1-9279-e063-6394a90a64532025-12-15Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
application number: M020
Glow ShieldZINC OXIDEKristina Lerner35be8766-1352-8967-e063-6294a90a896a2025-12-15Exact identifier
application number: M020
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386bb911-9dbb-30fb-e063-6394a90a5e4d2025-12-15Exact identifier
application number: M020
PURE Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c0261-68f9-6f27-e063-6294a90a82092025-12-15Exact identifier
application number: M020
PURE Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA JOLLA WELLNESS & AESTHETICS386c320b-22c3-7d35-e063-6394a90a4e0b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
application number: M020
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-903-40584110903401 CONTAINER in 1 CARTON (58411-903-40) / 150 mL in 1 CONTAINER1 container2025-01-01NoNoCurrent
58411-903-41584110903411 CONTAINER in 1 CARTON (58411-903-41) / 50 mL in 1 CONTAINER1 container2025-01-01NoNoCurrent