CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER

Product NDC
52685-380
11-digit product format
526850380
Labeler code
52685
Product ID
52685-380_acc7e724-215c-49b5-b751-511ae370ab44
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole and Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO CO., LTD.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-11-01
Marketing end
0000-00-00
Substance
ENSULIZOLE; OCTINOXATE
Active strength
430 mg/21.52g; mg/21.52g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct52685-380DDiscontinued by firm2026-10-23
excluded packagepackage52685-38052685-380-10DDiscontinued by firm2026-10-23

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52685-380-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52685-380-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52685-380-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52685-380-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52685-380-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52685-380-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52685-380-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52685-380-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52685-380-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52685-380-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52685-380-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52685-380-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52685-380-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52685-380-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52685-380-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52685-380-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52685-380-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52685-380-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52685-380-10IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52685-380-102023-09-21C16284748780-197449f38-c095-f6ea-e053-dbdaa90aa703cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER
52685-380-102019-11-13C16284748780-197449f38-c095-f6ea-e053-dbdaa90aa703cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EnsulizoleACTIVE INGREDIENT9YQ9DI1W42CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
EnsulizoleACTIVE MOIETY9YQ9DI1W42CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
BUPLEURUM FALCATUM ROOTINACTIVE INGREDIENTX04E310LUYCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
LAURYL BETAINEINACTIVE INGREDIENTY4P927Q133CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
TRIETHYLHEXANOININACTIVE INGREDIENT7K3W1BIU6KCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER (ENSULIZOLE AND OCTINOXATE) CREAM [SHISEIDO CO., LTD.]1