Home NDC 40046-0082 STUDIO FIX FLUID BROAD SPECTRUM SPF 15
Product NDC 40046-0082
11-digit product format 400460082
Labeler code 40046
Product ID 40046-0082_297ac7ef-664c-b36e-e063-6394a90aa6b1
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, TITANIUM DIOXIDE
Dosage form EMULSION
Route TOPICAL
Labeler MAKEUP ART COSMETICS
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-12
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 30; 10 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 40046-0082 UNFINISHED Active or certified unfinished drug listing 2026-10-21 unfinished package package 40046-0082 40046-0082-0 UNFINISHED Active or certified unfinished drug listing 2026-10-21
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 40046-0082-0 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 40046-0082-0 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 40046-0082-0 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 40046-0082-0 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 40046-0082-0 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 40046-0082-0 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 40046-0082-0 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 40046-0082-0 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 40046-0082-0 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 40046-0082-0 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 40046-0082-0 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 40046-0082-0 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 40046-0082-0 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 40046-0082-0 50b4072663b7…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 BROAD SPECTRUM SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 30 mg/mL TITANIUM DIOXIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40046-0082-1 STUDIO FIX FLUID BROAD SPECTRUM SPF 15 30 mL in 1 BOTTLE EMULSION 30 2 40046-0082-1 STUDIO FIX FLUID BROAD SPECTRUM SPF 15 1 in 1 CARTON EMULSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40046-0082 STUDIO FIX FLUID BROAD SPECTRUM SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) EMULSION [MAKEUP ART COSMETICS] 2 Current NDC, 2 package rows 20241219_fb59afc1-1dc9-f783-e053-6394a90a196b.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 03c7ca69-86f1-420c-9c4c-0bf2e8553c94 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ff6a85a4-b0c5-4c2e-a698-bb315203f51b 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 262b4cfc-71c3-485e-906f-a88fe33035a8 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 8N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 30964b87-1d7c-4dd1-8ab2-bf9b8eb2ee03 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 9N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 2cb4bad3-57d6-4e67-88ec-1776870c3eba 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00 Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ffd1ba9e-dd64-422a-bd69-596b5d80554d 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 00,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 64943a01-5193-4c04-b623-33ceb09f10fd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior df2e2d3f-8876-4197-bdfa-339b4f6a7571 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6cb5d7fa-4d40-46bd-9ef3-14368578cb33 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ae1e74f1-eb31-4da1-8b24-dae692d3637e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 0W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a5ce5568-708a-4af1-aa06-ea643c898bb1 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4fc4ce51-000a-42ee-952f-b4ce5f5d8a60 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ade16145-5267-4f01-bd99-f507087583f3 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 4b23d8e4-b0c3-44d7-b239-a2c7ae442a2d 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72471612-1ae0-493c-87c7-bf7257310e70 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 881ad126-d93f-4782-8ece-600d41a254d7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 27bb6424-9aa6-408a-a9f4-874cb60c8f1f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior ea170049-ec16-4c9d-a73d-368f6b747d57 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b6fb14f0-a3e3-4545-bb4a-f9c27190b11b 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6cb14dcf-8b70-40c3-882b-063d8922ce4c 2026-01-16 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 40046-0082-0 40046008200 180 mL in 1 BOTTLE (40046-0082-0) 180 ml 21-NOV-23 Current 40046-0082-1 40046008201 1 BOTTLE in 1 CARTON (40046-0082-1) / 30 mL in 1 BOTTLE 1 bottle 2023-05-12 No No Current