LIP CONDITIONER

Product NDC
40046-0053
11-digit product format
400460053
Labeler code
40046
Product ID
40046-0053_6615a397-12dd-44e8-ac96-f91bdd8b7e0f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
MAKE UP ART COSMETICS
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-01-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
8 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct40046-0053IInactivated by FDA2026-09-09
excluded packagepackage40046-005340046-0053-1IInactivated by FDA2026-09-09

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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40046-0053-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40046-0053-1IInactivated by FDAf5e01cc5f278…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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1IInactivated 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 packagepackage40046-0053-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0053-12020-01-31C16284748780-19d75b9d0-e0ef-f424-e053-dadaa90a57cefc29b3ba-8dde-4052-85c6-0189541b6824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0053-1LIP CONDITIONERSPF 151 in 1 CARTONLIPSTICK11
40046-0053-2LIP CONDITIONERSPF 154.8 g in 1 CARTRIDGELIPSTICK4.81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
OCTISALATEACTIVE MOIETY4X49Y0596WLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
ASTROCARYUM MURUMURU SEED BUTTERINACTIVE INGREDIENT12V64UPU6RLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
MYRISTYL LACTATEINACTIVE INGREDIENT1D822OC34XLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
SACCHARININACTIVE INGREDIENTFST467XS7DLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YILIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
WHEAT GERM OILINACTIVE INGREDIENT14C97E680PLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VLIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0053LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) LIPSTICK [MAKE UP ART COSMETICS]1Legacy NDC, 2 package rows20111027_fc29b3ba-8dde-4052-85c6-0189541b6824.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40046-0053-1400460053011 in 1 CARTONHistorical
40046-0053-2400460053024.8 g in 1 CARTRIDGE4.8 gHistorical