LBEL

Product NDC
14783-304
11-digit product format
147830304
Labeler code
14783
Product ID
14783-304_addec3e3-ea22-46cd-b788-e88efd85c920
Type
HUMAN OTC DRUG
Nonproprietary name
Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura International Ltd.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-19
Marketing end
0000-00-00
Substance
ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
0 g/mL; g/mL; g/mL; g/mL; g/mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14783-304DDiscontinued by firm2026-10-05
excluded packagepackage14783-30414783-304-02DDiscontinued by firm2026-10-05
excluded packagepackage14783-30414783-304-04DDiscontinued by firm2026-10-05
excluded packagepackage14783-30414783-304-05DDiscontinued 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 2 · 88 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 packagepackage14783-304-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14783-304-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14783-304-02DDiscontinued 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 packagepackage14783-304-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14783-304-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14783-304-02DDiscontinued 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 packagepackage14783-304-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14783-304-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14783-304-02DDiscontinued 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 packagepackage14783-304-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14783-304-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14783-304-02DDiscontinued 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 packagepackage14783-304-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14783-304-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14783-304-02DDiscontinued 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 packagepackage14783-304-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14783-304-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14783-304-02DDiscontinued by firmcdf11ea48f46…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 packagepackage14783-304-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14783-304-05IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14783-304-05IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14783-304-05IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14783-304-05IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14783-304-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14783-304-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14783-304-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14783-304-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14783-304-04IInactivated 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 packagepackage14783-304-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14783-304-05IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14783-304-04IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EnsulizoleACTIVE INGREDIENT9YQ9DI1W42LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
Titanium dioxideACTIVE INGREDIENT15FIX9V2JPLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
EnsulizoleACTIVE MOIETY9YQ9DI1W42LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
Titanium dioxideACTIVE MOIETY15FIX9V2JPLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
arginineINACTIVE INGREDIENT94ZLA3W45FLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
aspartic acidINACTIVE INGREDIENT30KYC7MIAILBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BALBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
dicaprylyl carbonateINACTIVE INGREDIENT609A3V1SUALBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
ethylparabenINACTIVE INGREDIENT14255EXE39LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
histidine monohydrochlorideINACTIVE INGREDIENT1D5Q932XM6LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
khaya senegalensis barkINACTIVE INGREDIENT1S7EDA839LLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
mannitolINACTIVE INGREDIENT3OWL53L36ALBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
nadideINACTIVE INGREDIENT0U46U6E8UKLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
peaINACTIVE INGREDIENTW4X7H8GYFMLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
pyridoxine hydrochlorideINACTIVE INGREDIENT68Y4CF58BVLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
sodium succinate anhydrousINACTIVE INGREDIENTV8ZGC8ISR3LBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
waterINACTIVE INGREDIENT059QF0KO0RLBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEELBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1
yeastINACTIVE INGREDIENT3NY3SM6B8ULBEL PROTEGE EXPERT (ENSULIZOLE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE) LOTION [VENTURA INTERNATIONAL LTD.]1