SHISEIDO ULTIMATE SUN PROTECTION

Product NDC
58411-253
11-digit product format
584110253
Labeler code
58411
Product ID
58411-253_934d88e8-7244-49f9-b0e1-419f4d2ab0d2
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
8406 mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58411-253DDiscontinued by firm2026-10-05
excluded packagepackage58411-25358411-253-10DDiscontinued by firm2026-10-05
excluded packagepackage58411-25358411-253-80DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58411-253-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58411-253-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58411-253-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58411-253-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58411-253-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58411-253-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58411-253-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58411-253-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58411-253-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58411-253-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58411-253-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58411-253-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58411-253-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58411-253-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58411-253-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58411-253-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58411-253-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58411-253-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58411-253-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58411-253-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58411-253-80557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09LSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ECTOINEINACTIVE INGREDIENT7GXZ3858RYSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ESHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
METHYL GLUCETH-10INACTIVE INGREDIENTN0MWT4C7WHSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENTTYP81E471FSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
PEG/PPG-14/7 DIMETHYL ETHERINACTIVE INGREDIENT6DNW9T7YT2SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB69SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903HSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
SOPHORA FLAVESCENS ROOTINACTIVE INGREDIENTIYR6K8KQ5KSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
SYZYGIUM JAMBOS LEAFINACTIVE INGREDIENT407Z4W5LFFSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1USHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GNSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RSHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ESHISEIDO ULTIMATE SUN PROTECTION (OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [SHISEIDO AMERICAS CORPORATION]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58411-253-10584110253101 BOTTLE, PLASTIC in 1 CARTON (58411-253-10) > 100 mL in 1 BOTTLE, PLASTIC2015-02-010000-00-00NoNoCurrent