CLE DE PEAU BEAUTE UV PROTECTION

Product NDC
52686-259
11-digit product format
526860259
Labeler code
52686
Product ID
52686-259_177f1296-f84a-40f1-9b0a-77d3f5f70649
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Oxybenzone, and Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO AMERICA INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE
Active strength
4 g/54.91g; g/54.91g; g/54.91g; g/54.91g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct52686-259DDiscontinued by firm2026-10-05
excluded packagepackage52686-25952686-259-60DDiscontinued 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 · 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60DDiscontinued 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 packagepackage52686-259-60IInactivated 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 packagepackage52686-259-60IInactivated 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 packagepackage52686-259-60IInactivated 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 packagepackage52686-259-60IInactivated 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 packagepackage52686-259-60IInactivated 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 packagepackage52686-259-60IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52686-259-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
52686-259-602023-10-06C16284748780-19d75b9d1-1b60-f424-e053-dadaa90a57ceCLE DE PEAU BEAUTE UV PROTECTION CREAM
52686-259-602020-01-31C16284748780-19d75b9d1-1b60-f424-e053-dadaa90a57ceCLE DE PEAU BEAUTE UV PROTECTION CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
Zinc oxideACTIVE INGREDIENTSOI2LOH54ZCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
OctocryleneACTIVE MOIETY5A68WGF6WMCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
Zinc oxideACTIVE MOIETYSOI2LOH54ZCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
2-O-ETHYL ASCORBIC ACIDINACTIVE INGREDIENT801M14RK9KCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
BUPLEURUM FALCATUM ROOTINACTIVE INGREDIENTX04E310LUYCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
CRATAEGUS MONOGYNA FLOWERINACTIVE INGREDIENTNT52AMP29JCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB7CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ECLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
MICAINACTIVE INGREDIENTV8A1AW0880CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ACLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB69CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FFCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903HCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
THIOTAURINEINACTIVE INGREDIENTNQZ2D7AO62CLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
TURMERICINACTIVE INGREDIENT856YO1Z64FCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECLE DE PEAU BEAUTE UV PROTECTION (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICA INC.]1