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 165 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb25154-e4e3-efc7-e053-2a95a90a2df62025-11-10WarningsExact identifier
application number: M020
ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50ZINC OXIDECatherine Hinds Company, Inc.956e6643-51c9-49c4-bd68-f5ee1b0ae4e02025-11-10WarningsExact identifier
application number: M020
GoodSense SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inc.c85d59a1-6ae1-bb2e-e053-2995a90af20e2025-11-09WarningsExact identifier
application number: M020
GoodSense SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Geiss, Destin, & Dunn, Inc.c85c5d2b-35f6-2fd5-e053-2995a90a4a532025-11-09WarningsExact identifier
application number: M020
Walgreens SPF 50 Tinted Mineral FluidTITANIUM DIOXIDEWalgreens345918e3-95f8-404c-e063-6394a90a3fca2025-11-09WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATEDistribuidora Comercial Jafra, S.A. de C.V.ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d690d5d1-e1fa-404f-a17e-7b97be17b44a2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2fbdeff7-4880-49ef-bb4d-e033d18e04592025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
application number: M020
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
application number: M020
e l f Holy Hydration Face SPF 30 Sunscreen,AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc44a8028b-731d-4561-b2e3-ee9738ad8d302025-11-07WarningsExact identifier
application number: M020
e l f Sun Boss Gloss SPF 25 Sunscreen Its your MauveZINC OXIDEe.l.f. Cosmetics, Inc.bce21361-c92c-40ad-a373-db3b83b15b8a2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer SunburstAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc49d912c7-259a-487d-a523-b14031bfaab62025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer SunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d2025-11-07WarningsExact identifier
application number: M020
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer SunbeamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.f818f524-0263-4f89-b4f3-4dd83d688e7e2025-11-07WarningsExact 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