LBel

Product NDC
14783-550
11-digit product format
147830550
Labeler code
14783
Product ID
14783-550_43d6cd8f-8279-4775-953c-44fe3a6e0a11
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Ventura International, Limited
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-19
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
0 g/g; g/g; 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 productproduct14783-550DDiscontinued by firm2026-10-15
excluded packagepackage14783-55014783-550-06DDiscontinued by firm2026-10-15

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 packagepackage14783-550-06DDiscontinued 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 packagepackage14783-550-06DDiscontinued 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 packagepackage14783-550-06DDiscontinued 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 packagepackage14783-550-06DDiscontinued 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 packagepackage14783-550-06DDiscontinued by firmcfe11265f3b6…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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated 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 packagepackage14783-550-06IInactivated by FDA110d247fa046…a55b01930146…

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
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
Titanium dioxideACTIVE INGREDIENT15FIX9V2JPLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OctocryleneACTIVE MOIETY5A68WGF6WMLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
Titanium dioxideACTIVE MOIETY15FIX9V2JPLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2ULBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
c12-15 alkyl benzoateINACTIVE INGREDIENTA9EJ3J61HQLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
candelilla waxINACTIVE INGREDIENTWL0328HX19LBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
castor oilINACTIVE INGREDIENTD5340Y2I9GLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
cetearyl glucosideINACTIVE INGREDIENT09FUA47KNALBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
cholesterolINACTIVE INGREDIENT97C5T2UQ7JLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
octyldodecanolINACTIVE INGREDIENT461N1O614YLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZELBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
petrolatumINACTIVE INGREDIENT4T6H12BN9ULBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
shea butterINACTIVE INGREDIENTK49155WL9YLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VLBEL PROTEGE EXPERT (OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND TITANIUM DIOXIDE) CREAM [VENTURA INTERNATIONAL, LIMITED]1