LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15

Product NDC
14783-803
11-digit product format
147830803
Labeler code
14783
Product ID
14783-803_912ed4b3-0ad8-4c41-8020-469e753ab147
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura International LTD
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-22
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
0 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14783-803DDiscontinued by firm2026-10-12
excluded packagepackage14783-80314783-803-02DDiscontinued 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 packagepackage14783-803-02DDiscontinued 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 packagepackage14783-803-02DDiscontinued 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 packagepackage14783-803-02DDiscontinued 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 packagepackage14783-803-02DDiscontinued 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 packagepackage14783-803-02DDiscontinued 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02IInactivated 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 packagepackage14783-803-02EExcluded 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#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OctisalateACTIVE INGREDIENT4X49Y0596WLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OctocryleneACTIVE INGREDIENT5A68WGF6WMLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
AvobenzoneACTIVE MOIETYG63QQF2NOXLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OctisalateACTIVE MOIETY4X49Y0596WLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OctocryleneACTIVE MOIETY5A68WGF6WMLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
acaciaINACTIVE INGREDIENT5C5403N26OLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
albizia julibrissin barkINACTIVE INGREDIENT0J9G6W44DVLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
c20-22 alcoholsINACTIVE INGREDIENTO4M0347C6ALBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
c20-22 alkyl phosphateINACTIVE INGREDIENTL4VKP0Y7RPLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
cyclomethicone 6INACTIVE INGREDIENTXHK3U310BALBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
hydrogenated palm glyceridesINACTIVE INGREDIENTYCZ8EM144QLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
palmitoyl lysyldioxymethionyllysineINACTIVE INGREDIENTT7A529FB8OLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
pentylene glycolINACTIVE INGREDIENT50C1307PZGLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
waterINACTIVE INGREDIENT059QF0KO0RLBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEELBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [VENTURA INTERNATIONAL LTD]1