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 2026-10-20 unfinished package package 40046-0082 40046-0082-0 UNFINISHED Active or certified unfinished drug listing 2026-10-20
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 44 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TRUST MD SPF30 STEM CELL FACE OCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDE Guangzhou Yapheon Health Industry Co., Ltd. 4f2ca12c-bc6f-61b8-e063-6294a90a0d7e 2026-04-11 Warnings Exact identifier application number: M020 MIDHA Rice Daily Moisture Sun Cream AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MIDHA Cosmetic Co.,Ltd. 4b394107-7830-c2c6-e063-6294a90a07d9 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Deep OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f15d5ba-6396-56bf-e063-6394a90adb06 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Light OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f165895-aa84-e215-e063-6394a90a6256 2026-04-10 Warnings Exact identifier application number: M020 Abib Dewy tinted sunscreen Glow tube Medium OCTISALATE, OCTOCRYLENE, ZINC OXIDE FOURCOMPANY CO., LTD. 4f16b8a4-4279-5f79-e063-6294a90a353d 2026-04-10 Warnings Exact identifier application number: M020 Sheer Touch Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE Amazon.com Services LLC f5ca0416-548c-4be0-a69e-c7e1b52aba95 2026-04-10 Warnings, Adverse reactions Exact identifier application number: M020 LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHT ZINC OXIDE The Green Cricket Inc c56fd135-f46a-51ce-e053-2a95a90ab7b3 2026-04-10 Warnings Exact identifier application number: M020 CorTex SunX 50 Thick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CoreTex Products Inc f67a6c6c-c314-1c9d-e053-2a95a90a7f1a 2026-04-10 Warnings Exact identifier application number: M020 Nu Skin 180 Degree UV Block Hydrator SPF 18 OCTINOXATE AND ZINC OXIDE NSE Products, Inc. b9635e59-bb08-4167-b7ba-54c3fc712589 2026-04-09 Warnings Exact identifier application number: M020 Sport Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 79c6fe2a-34c2-44cc-81bc-796c4463d2a6 2026-04-09 Warnings, Adverse reactions Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdbae5-84ec-7b1d-e063-6294a90a2878 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Prickly Pear Lip Balm SPF 15 SUNSCREEN LIP BALM Arizona Sun Products 11e9cb25-6ff8-a121-e063-6394a90a849e 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 11e8b612-29be-47ed-e063-6394a90ab9e7 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun ProductsSurfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fdcfd0-8b24-7efc-e063-6294a90af7fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Cycleblok Sunscreen SUNSCREEN Arizona Sun Products 11e71a84-12d1-2d4f-e063-6294a90adcd6 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Bikerblok Sunscreen SUNSCREEN Arizona Sun Products 11e6eafd-f967-b748-e063-6394a90aabfd 2026-04-09 Warnings Exact identifier application number: M020 YSE Beauty Skin Glow Primer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MSS Beauty LLC 6a318e27-14e5-488e-ac19-010f69cb743d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen Kids Water Resistant SPF 30 SUNSCREEN Arizona Sun Products 116ed17c-3b38-5e96-e063-6294a90a4246 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun SPF 45 Surfblok Sunscreen SUNSCREEN Arizona Sun Products 11e76815-9316-555d-e063-6294a90aeb81 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Moisturizer SPF 3 MOISTURIZER Arizona Sun Products 1171af26-3040-552c-e063-6294a90ae220 2026-04-09 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