FDA.reportPublic FDA data

SHISEIDO ULTIMATE SUN PROTECTOR

Product NDC
58411-971
11-digit product format
584110971
Labeler code
58411
Product ID
58411-971_4a041a52-40c7-099d-e063-6394a90a766e
Type
HUMAN OTC DRUG
Nonproprietary name
OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
OCTOCRYLENE; OCTISALATE; ZINC OXIDE
Active strength
1.8105; 1.8105; 11.7079 g/50mL; g/50mL; g/50mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE1.8105 g/50mL
OCTISALATE1.8105 g/50mL
ZINC OXIDE11.7079 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal 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
ce6a28c1-56e6-4105-bc9d-9d1986ead420Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-971-60SHISEIDO ULTIMATE SUN PROTECTOR1 in 1 BOXCREAM12
58411-971-60SHISEIDO ULTIMATE SUN PROTECTOR50 mL in 1 TUBECREAM502

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 175 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEDEWYTREE CO. ,LTD2f1ca6e0-f689-57c7-e063-6394a90a3da52025-10-21WarningsExact identifier
application number: M020
TOSOWOONG Rice Glow SunScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMANTONG Co., Ltd.3e9120fd-1c2f-1546-e063-6394a90a9e462025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - BuffHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.857666da-2b4a-4a4a-aa25-ed6fd9b6a1632025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V62031860-2e28-4b25-82bd-29b874b24d842025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - CocoaHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.40e6473a-8363-4503-bde0-6c151296fb342025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7f4a185c-85c7-43bf-8695-c01a3aecec0d2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - NaturalHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V383aabdf-3feb-4407-9d85-27c11cb3e78c2025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - ShellHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V4585b1c8-e477-44d7-a3ad-a9efc3d699b72025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft IvoryHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V1e9efb61-06ad-4d2d-a81d-46aba72f75142025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- BisqueHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.Vffc421e1-26eb-44e7-b03c-5fab761a51b22025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural TanHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V3617d26e-a94c-4665-988b-95dbbc5270172025-10-21WarningsExact identifier
application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- HoneyHOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.55be05c0-429a-4ae0-bb86-1120bb1905ff2025-10-21WarningsExact identifier
application number: M020
Sun face protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e1ced7-dafa-c71e-e053-2995a90a95502025-10-21WarningsExact identifier
application number: M020
Jafra Sun sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b9316e16-c571-4a5c-e053-2995a90ac6a82025-10-21WarningsExact identifier
application number: M020
Jafra Sun tinted face protector sunscreen broad spectrum 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8df67f8-57d9-ddc1-e053-2995a90a50c62025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
application number: M020
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC0b625d48-9632-0464-e063-6394a90a9adc2025-10-21WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
application number: M020
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC4198cfc0-a696-e279-e063-6294a90ac2392025-10-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-971-60584110971601 TUBE in 1 BOX (58411-971-60) / 50 mL in 1 TUBE1 tube2025-03-01NoNoCurrent