BENEFIANCE PROTECTIVE HAND REVITALIZER

Product NDC
52686-106
11-digit product format
526860106
Labeler code
52686
Product ID
52686-106_d73e6a8d-018b-404c-b626-97738c62cec8
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE
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
Active strength
5550 mg/75g
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 productproduct52686-106DDiscontinued by firm2026-10-12
excluded packagepackage52686-10652686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60DDiscontinued 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60IInactivated 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 packagepackage52686-106-60EExcluded 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
52686-106-602023-09-25C16284748780-19d75b9d0-87f4-f424-e053-dadaa90a57ceBENEFIANCE PROTECTIVE HAND REVITALIZER
52686-106-602020-01-31C16284748780-19d75b9d0-87f4-f424-e053-dadaa90a57ceBENEFIANCE PROTECTIVE HAND REVITALIZER

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
BEHENIC ACIDINACTIVE INGREDIENTH390488X0ABENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
DIPHENYLSILOXY PHENYL TRIMETHICONEINACTIVE INGREDIENTI445L28B12BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
HYDROGENATED PALM OILINACTIVE INGREDIENT257THB963HBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
PEG-5 GLYCERYL STEARATEINACTIVE INGREDIENT8CAC4NQ872BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATEINACTIVE INGREDIENT61R4GJ48ERBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903HBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
TRANEXAMIC ACIDINACTIVE INGREDIENT6T84R30KC1BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GNBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]1