LBEL

Product NDC
14783-434
11-digit product format
147830434
Labeler code
14783
Product ID
14783-434_3cc7d79e-48a5-440a-a5e7-ca9048ee07f0
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura International Ltd.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-11-26
Marketing end
0000-00-00
Substance
AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
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 productproduct14783-434DDiscontinued by firm2026-10-16
excluded packagepackage14783-43414783-434-01DDiscontinued by firm2026-10-16
excluded packagepackage14783-43414783-434-04DDiscontinued by firm2026-10-16
excluded packagepackage14783-43414783-434-05DDiscontinued by firm2026-10-16

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 packagepackage14783-434-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14783-434-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14783-434-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14783-434-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14783-434-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14783-434-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14783-434-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage14783-434-05DDiscontinued 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 packagepackage14783-434-05IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14783-434-04IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14783-434-04IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14783-434-04IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14783-434-04IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14783-434-04IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14783-434-04IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14783-434-04IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14783-434-04IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage14783-434-01IInactivated 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 packagepackage14783-434-05IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14783-434-04IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage14783-434-01IInactivated 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
AvobenzoneACTIVE INGREDIENTG63QQF2NOXLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
EnsulizoleACTIVE INGREDIENT9YQ9DI1W42LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
AvobenzoneACTIVE MOIETYG63QQF2NOXLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
EnsulizoleACTIVE MOIETY9YQ9DI1W42LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OctocryleneACTIVE MOIETY5A68WGF6WMLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
alcoholINACTIVE INGREDIENT3K9958V90MLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
ceteth-20INACTIVE INGREDIENTI835H2IHHXLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
dicaprylyl carbonateINACTIVE INGREDIENT609A3V1SUALBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
edetate sodiumINACTIVE INGREDIENTMP1J8420LULBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
moth beanINACTIVE INGREDIENTH7938ON8E5LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
peg-75 stearateINACTIVE INGREDIENTOT38R0N74HLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
phenethyl benzoateINACTIVE INGREDIENT0C143929GKLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
sorbic acidINACTIVE INGREDIENTX045WJ989BLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
steareth-20INACTIVE INGREDIENTL0Q8IK9E08LBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
triethylhexanoinINACTIVE INGREDIENT7K3W1BIU6KLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
waterINACTIVE INGREDIENT059QF0KO0RLBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEELBEL DERMO CLARITE (AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD.]1