SHISEIDO URBAN ENVIRONMENT UV PROTECTION

Product NDC
52686-271
11-digit product format
526860271
Labeler code
52686
Product ID
52686-271_7cf0654f-6a7c-53e2-e053-2a91aa0a32a7
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO AMERICA INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active strength
1583 mg/54.6g; mg/54.6g; mg/54.6g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52686-271IInactivated by FDA2026-10-05
excluded packagepackage52686-27152686-271-60IInactivated by FDA2026-10-05

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 packagepackage52686-271-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52686-271-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52686-271-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52686-271-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52686-271-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52686-271-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52686-271-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52686-271-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52686-271-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52686-271-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52686-271-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52686-271-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52686-271-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52686-271-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52686-271-601332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-271-602024-01-30C16284748780-11030e365-3a67-111a-e063-dadaa90a10e2SHISEIDO URBAN ENVIRONMENT UV PROTECTION CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52686-271-60SHISEIDO URBAN ENVIRONMENT UV PROTECTION1 in 1 CARTONCREAM13
52686-271-60SHISEIDO URBAN ENVIRONMENT UV PROTECTION54.6 g in 1 TUBECREAM54.63

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20YSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ECTOINEINACTIVE INGREDIENT7GXZ3858RYSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ISODODECANEINACTIVE INGREDIENTA8289P68Y2SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
METHYL GLUCETH-10INACTIVE INGREDIENTN0MWT4C7WHSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
ONONIS SPINOSA ROOTINACTIVE INGREDIENTFD2FMC53M1SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
OXYBENZONEINACTIVE INGREDIENT95OOS7VE0YSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
SYZYGIUM JAMBOS LEAFINACTIVE INGREDIENT407Z4W5LFFSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
THIOTAURINEINACTIVE INGREDIENTNQZ2D7AO62SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ESHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ESHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52686-271SHISEIDO URBAN ENVIRONMENT UV PROTECTION (OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]3Legacy NDC, 2 package rows20181214_fb4dfdf9-2ee4-42ed-8d95-07f7e1b24495.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52686-271-60526860271601 TUBE in 1 CARTON (52686-271-60) > 54.6 g in 1 TUBE1 tube2012-10-010000-00-00NoNoCurrent