STUDIO FIX FLUID SPF 15 BROAD SPECTRUM

Product NDC
40046-0072
11-digit product format
400460072
Labeler code
40046
Product ID
40046-0072_2a15bb87-bf9d-336e-e063-6294a90a85f2
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
MAKEUP ART COSMETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-01
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
25; 10 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage40046-0072-005c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage40046-0072-905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage40046-0072-048b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage40046-0072-948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage40046-0072-027f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage40046-0072-927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage40046-0072-08d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage40046-0072-98d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage40046-0072-0d1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage40046-0072-9d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage40046-0072-050b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage40046-0072-950b4072663b7…eae3003ed65e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE25 mg/mL
TITANIUM DIOXIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff48435d-245a-4037-9afb-caee83c4c415Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0072-12022-08-04C16284748780-1e4f33bdf-a796-d8a0-e053-dadaa90a6e4eSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM
40046-0072-12022-07-29C16284748780-1e4f33bdf-a796-d8a0-e053-dadaa90a6e4eSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0072-1STUDIO FIX FLUID SPF 15 BROAD SPECTRUM30 mL in 1 BOTTLELIQUID3010
40046-0072-1STUDIO FIX FLUID SPF 15 BROAD SPECTRUM1 in 1 CARTONLIQUID110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RASTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
chloroxylenolINACTIVE INGREDIENT0F32U78V2QSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
chromic oxideINACTIVE INGREDIENTX5Z09SU859STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
dipropylene glycolINACTIVE INGREDIENTE107L85C40STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
disteardimonium hectoriteINACTIVE INGREDIENTX687XDK09LSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
laureth-7INACTIVE INGREDIENTZ95S6G8201STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
magnesium sulfateINACTIVE INGREDIENTDE08037SABSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
peg/ppg-18/18 dimethiconeINACTIVE INGREDIENT9H0AO7T794STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)INACTIVE INGREDIENT255PIF62MSSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
propylene carbonateINACTIVE INGREDIENT8D08K3S51ESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
saccharina latissimaINACTIVE INGREDIENT68CMP2MB55STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
sorbic acidINACTIVE INGREDIENTX045WJ989BSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
sorbitan sesquioleateINACTIVE INGREDIENT0W8RRI5W5ASTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
tocopherolINACTIVE INGREDIENTR0ZB2556P8STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
waterINACTIVE INGREDIENT059QF0KO0RSTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEESTUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0072STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]10Current NDC, Legacy NDC, 2 package rows20241227_ff48435d-245a-4037-9afb-caee83c4c415.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 77 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior03c7ca69-86f1-420c-9c4c-0bf2e8553c942026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorff6a85a4-b0c5-4c2e-a698-bb315203f51b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior262b4cfc-71c3-485e-906f-a88fe33035a82026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee032026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2cb4bad3-57d6-4e67-88ec-1776870c3eba2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorffd1ba9e-dd64-422a-bd69-596b5d80554d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64943a01-5193-4c04-b623-33ceb09f10fd2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordf2e2d3f-8876-4197-bdfa-339b4f6a75712026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb5d7fa-4d40-46bd-9ef3-14368578cb332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorae1e74f1-eb31-4da1-8b24-dae692d3637e2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora5ce5568-708a-4af1-aa06-ea643c898bb12026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4fc4ce51-000a-42ee-952f-b4ce5f5d8a602026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorade16145-5267-4f01-bd99-f507087583f32026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior72471612-1ae0-493c-87c7-bf7257310e702026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior881ad126-d93f-4782-8ece-600d41a254d72026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior27bb6424-9aa6-408a-a9f4-874cb60c8f1f2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorea170049-ec16-4c9d-a73d-368f6b747d572026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6fb14f0-a3e3-4545-bb4a-f9c27190b11b2026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6cb14dcf-8b70-40c3-882b-063d8922ce4c2026-01-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40046-0072-1400460072011 BOTTLE in 1 CARTON (40046-0072-1) / 30 mL in 1 BOTTLE1 bottle2005-12-010000-00-00NoNoCurrent