LBel

Product NDC
14783-083
11-digit product format
147830083
Labeler code
14783
Product ID
14783-083_84e83063-f93c-4935-a846-5bb9decb9ebe
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Oxybenzone, and Titanium Dioxide
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Ventura International LTD
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-15
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength
0 g/4g; g/4g; g/4g
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 productproduct14783-083DDiscontinued by firm2026-10-15
excluded packagepackage14783-08314783-083-62DDiscontinued 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 packagepackage14783-083-62DDiscontinued 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 packagepackage14783-083-62DDiscontinued 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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 packagepackage14783-083-62IInactivated 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
14783-083-622025-05-19C16284748780-1956f9ecf-c963-621f-e053-dbdaa90a74adCOULEUR LUXE SUPREME XP
14783-083-622019-10-21C16284748780-1956f9ecf-c963-621f-e053-dbdaa90a74adCOULEUR LUXE SUPREME XP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD51LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
OxybenzoneACTIVE INGREDIENT95OOS7VE0YLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
OctinoxateACTIVE MOIETY4Y5P7MUD51LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
OxybenzoneACTIVE MOIETY95OOS7VE0YLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
arachidyl propionateINACTIVE INGREDIENTQV5DAH3MSBLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
candelilla waxINACTIVE INGREDIENTWL0328HX19LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
castor oilINACTIVE INGREDIENTD5340Y2I9GLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
D&C red no. 28INACTIVE INGREDIENT767IP0Y5NHLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
D&C red no. 6INACTIVE INGREDIENT481744AI4OLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
decyl oleateINACTIVE INGREDIENTZGR06DO97TLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
ethyl linoleateINACTIVE INGREDIENTMJ2YTT4J8MLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7ULBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
micaINACTIVE INGREDIENTV8A1AW0880LBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
oleyl alcoholINACTIVE INGREDIENT172F2WN8DVLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5ALBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
talcINACTIVE INGREDIENT7SEV7J4R1ULBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
vitamin a palmitateINACTIVE INGREDIENT1D1K0N0VVCLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VLBEL (OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE) LIPSTICK [VENTURA INTERNATIONAL LTD]1