ESIKA

Product NDC
13537-332
11-digit product format
135370332
Labeler code
13537
Product ID
13537-332_da7ce050-9728-4e54-8aa9-a0502aceef72
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Oxybenzone, and Titanium Dioxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Ventura Corporation (San Juan, P.R)
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-17
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
0 g/g; g/g; g/g
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 productproduct13537-332DDiscontinued by firm2026-10-12
excluded packagepackage13537-33213537-332-02DDiscontinued 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 · 44 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 packagepackage13537-332-02DDiscontinued 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 packagepackage13537-332-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13537-332-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13537-332-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13537-332-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13537-332-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13537-332-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13537-332-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13537-332-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13537-332-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13537-332-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13537-332-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13537-332-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13537-332-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13537-332-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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 packagepackage13537-332-02IInactivated 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
13537-332-022025-05-02C16284748780-1960f7f55-c2ed-8e05-e053-dbdaa90a074aēsika 3-in-1 Pro Make Up Foundation SPF 20
13537-332-022019-10-29C16284748780-1960f7f55-c2ed-8e05-e053-dbdaa90a074aēsika 3-in-1 Pro Make Up Foundation SPF 20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
OctinoxateACTIVE MOIETY4Y5P7MUD51ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
OxybenzoneACTIVE MOIETY95OOS7VE0YESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
candelilla waxINACTIVE INGREDIENTWL0328HX19ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ceresinINACTIVE INGREDIENTQ1LS2UJO3AESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
cetearyl glucosideINACTIVE INGREDIENT09FUA47KNAESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
cholesterolINACTIVE INGREDIENT97C5T2UQ7JESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ethylhexyl palmitateINACTIVE INGREDIENT2865993309ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ethylparabenINACTIVE INGREDIENT14255EXE39ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
micaINACTIVE INGREDIENTV8A1AW0880ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
octyldodecanolINACTIVE INGREDIENT461N1O614YESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
starch, cornINACTIVE INGREDIENTO8232NY3SJESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VESIKA (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) POWDER [VENTURA CORPORATION (SAN JUAN, P.R)]1