STUDIO SCULPT

Product NDC
40046-0032
11-digit product format
400460032
Labeler code
40046
Product ID
40046-0032_5a09d299-9c80-4b6b-bdeb-4ffe9f290c77
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
MAKE UP ART COSMETICS
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2008-09-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
7 mL/100mL; mL/100mL
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 productproduct40046-0032IInactivated by FDA2026-09-09
excluded packagepackage40046-003240046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1IInactivated 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 packagepackage40046-0032-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0032-12020-01-31C16284748780-19d75b9d0-0ed4-f424-e053-dadaa90a57ce21045130-f8d5-465d-8628-c6053e95bc55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0032-1STUDIO SCULPTSPF 15 FOUNDATION1 in 1 CARTONLIQUID11
40046-0032-2STUDIO SCULPTSPF 15 FOUNDATION40 mL in 1 TUBELIQUID401

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
TAMARINDUS INDICA SEEDINACTIVE INGREDIENT6AHP8A7OMLSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1
WATERINACTIVE INGREDIENT059QF0KO0RSTUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0032STUDIO SCULPT SPF 15 FOUNDATION (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [MAKE UP ART COSMETICS]1Legacy NDC, 2 package rows20110301_21045130-f8d5-465d-8628-c6053e95bc55.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40046-0032-1400460032011 in 1 CARTONHistorical
40046-0032-24004600320240 mL in 1 TUBE40 mlHistorical