CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES

Product NDC
52685-191
11-digit product format
526850191
Labeler code
52685
Product ID
52685-191_dc6982b3-31a5-4423-9d95-947ce6e1992a
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Titanium dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO CO., LTD.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-09-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1160 mg/40g; mg/40g
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 productproduct52685-191DDiscontinued by firm2026-10-12
excluded packagepackage52685-19152685-191-60DDiscontinued by firm2026-10-12

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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60DDiscontinued 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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 packagepackage52685-191-60IInactivated 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
52685-191-602023-09-11C16284748780-197449f38-c49a-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES
52685-191-602019-11-13C16284748780-197449f38-c49a-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
Titanium dioxideACTIVE INGREDIENT15FIX9V2JPCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
Titanium dioxideACTIVE MOIETY15FIX9V2JPCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ALUMINUM DISTEARATEINACTIVE INGREDIENT7P1HP1B9UICLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2ECLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX4CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB69CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FFCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
TRIMETHYLSILOXYSILICATE (M/Q 0.66)INACTIVE INGREDIENT5041RX63GNCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO CO., LTD.]1