STUDIO FIX FLUID

Product NDC
40046-0050
11-digit product format
400460050
Labeler code
40046
Product ID
40046-0050_9c8e9fd8-4461-4da6-9b00-5090973c5df9
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
MAKEUP ART COSMETICS
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-12-01
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
3 mL/100mL; mL/100mL
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 productproduct40046-0050IInactivated by FDA2026-08-11
excluded packagepackage40046-005040046-0050-1IInactivated by FDA2026-08-11

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 NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40046-0050-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40046-0050-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40046-0050-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40046-0050-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40046-0050-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40046-0050-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40046-0050-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40046-0050-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40046-0050-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40046-0050-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40046-0050-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40046-0050-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40046-0050-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40046-0050-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40046-0050-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage40046-0050-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage40046-0050-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage40046-0050-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage40046-0050-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage40046-0050-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage40046-0050-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage40046-0050-1110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0050-12019-10-29C16284748780-1960f7f55-c527-8e05-e053-dbdaa90a074a9f5c0b30-ab8a-4217-b2cc-68352d129d66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0050-1STUDIO FIX FLUIDSPF 151 in 1 CARTONLOTION11
40046-0050-2STUDIO FIX FLUIDSPF 1530 mL in 1 BOTTLELOTION301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
MAGNESIUM SULFATE, UNSPECIFIEDINACTIVE INGREDIENTDE08037SABSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)INACTIVE INGREDIENT255PIF62MSSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51ESTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
SEAWEEDINACTIVE INGREDIENT477TV3P5UXSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ESTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
TRIMETHYLSILANEINACTIVE INGREDIENT9L70DJH2K0STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
WATERINACTIVE INGREDIENT059QF0KO0RSTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESTUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0050STUDIO FIX FLUID SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LOTION [MAKEUP ART COSMETICS]1Legacy NDC, 2 package rows20110829_9f5c0b30-ab8a-4217-b2cc-68352d129d66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
40046-0050-1400460050011 in 1 CARTONHistorical
40046-0050-24004600500230 mL in 1 BOTTLE30 mlHistorical