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 2026-10-16 unfinished package package 40046-0082 40046-0082-0 UNFINISHED Active or certified unfinished drug listing 2026-10-16
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 27 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNFORGETTABLE TOTAL FACE PROTECTION FACE SHIELD CLASSIC ZINC OXIDE Colorescience d46533c7-c92d-d161-e053-2995a90a8e4b 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Glow ZINC OXIDE Colorescience cdb5397a-c463-4b41-e053-2a95a90a9e03 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Matte ZINC OXIDE Colorescience cd879b3e-16a2-2cca-e053-2a95a90a14f8 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Body Shield ZINC OXIDE Colorescience cdb413bb-58ab-1e0f-e053-2995a90aab0f 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Flex ZINC OXIDE Colorescience cdb55347-aedd-4de6-e053-2a95a90afec7 2026-05-21 Warnings Exact identifier application number: M020 Odacite Flex Perfecting Mineral Drops Tinted Sunscreen ZINC OXIDE Odacite 52560b2d-ebb5-5d96-e063-6294a90a15ee 2026-05-21 Warnings Exact identifier application number: M020 Sunforgettable Total Protection Face Shield Bronze ZINC OXIDE Colorescience cdb577e4-5c80-7eac-e053-2a95a90a105b 2026-05-21 Warnings Exact identifier application number: M020 Mineral SPF 30 Moisturizer MINERAL SPF 30 MOISTURIZER Dont Run Out Inc (DBA: Public Goods) 52462e7e-0c2c-6b64-e063-6394a90a4230 2026-05-21 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52564e2f-983d-89ba-e063-6394a90ab424 2026-05-21 Warnings Exact identifier application number: M020 DRMTLGY Radiance Powder TITANIUM DIOXIDE, ZINC OXIDE DRMTLGY 15bda8d5-8c3c-6ba5-e063-6394a90a82d9 2026-05-21 Warnings Exact identifier application number: M020 Agent Natuer holi (sun) dewy tinted skin drops ZINC OXIDE Agent Natuer 043734b8-9aee-cdf1-e063-6294a90aec60 2026-05-21 Warnings Exact identifier application number: M020 Organys Derma Made ZINC OXIDE Organys Beauty 09bb5f97-f4db-a2d4-e063-6394a90a84fd 2026-05-21 Warnings Exact identifier application number: M020 Skin Metal Green Stealth ZINC OXIDE Skin Metal 47f562cc-48cc-97f9-e063-6294a90a7216 2026-05-21 Warnings Exact identifier application number: M020 Blume Sunburst Sunscreen ZINC OXIDE Blume 21ef2c6b-8ae7-8bcf-e063-6294a90ae9e1 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST13 KAMARI) ZINC OXIDE Ilia, Inc. b595ca2c-177e-b357-e053-2995a90a54f6 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6 ORA) ZINC OXIDE Ilia, Inc. b59537d4-e1d8-53e4-e053-2995a90a2ce3 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16 PAVONES) ZINC OXIDE Ilia, Inc. b595f1e9-36f7-615d-e053-2a95a90abb1c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2.5 SOMBRIO) ZINC OXIDE Ilia, Inc. b97dc2ac-dd6d-403d-e053-2995a90a0d9c 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14 DOMINICA) ZINC OXIDE Ilia, Inc. b595db16-7969-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11 MATIRA) ZINC OXIDE Ilia, Inc. b595b5f0-dd3d-79ef-e053-2a95a90ad9fb 2026-05-21 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