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 16 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light ZINC OXIDE REJUVA MINERALS INC 2abccc86-01d4-e45c-e063-6294a90a7f8b 2026-07-02 Warnings Exact identifier application number: M020 OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige TITANIUM DIOXIDE LG H&H Co., Ltd. d307471c-6cc6-ce48-e053-2995a90a3e02 2026-07-02 Warnings Exact identifier application number: M020 Sunscreen SPF 50 AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% Worthy Promotional Products f5e2a412-e891-411d-85da-89f38cd61a9b 2026-07-02 Warnings Exact identifier application number: M020 Bath and Body Works SPF Bronze Kiss AVOBENZONE,HOMOSALATE,OCTISALATE Bath & Body Works, Inc. 5606c57b-7fdb-4317-e063-6294a90a996c 2026-07-02 Warnings Exact identifier application number: M020 Evereden Kids Mineral Sunscreen SPF 30 ZINC OXIDE Eden Brands Inc bba219a4-de83-76fd-e053-2995a90a2d69 2026-07-01 Warnings Exact identifier application number: M020 Kids Mineral Face Cream SPF20 ZINC OXIDE Eden Brands Inc fbfccb0c-e459-3282-e053-6394a90ad95d 2026-07-01 Warnings Exact identifier application number: M020 Evereden Fluid Silk Mineral Sunscreen PRO SPF50 TITANIUM DIOXIDE, ZINC OXIDE Eden Brands Inc. 2cb7773f-9a05-ad02-e063-6294a90af024 2026-07-01 Warnings Exact identifier application number: M020 Zinc Oxide 20% SUNSCREEN SPF 50 The Beach Rooster c2e57236-f184-4fa8-8fd5-c44cbf230058 2026-07-01 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID WATERY SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 557477a2-def8-740b-e063-6294a90ad287 2026-06-30 Warnings Exact identifier application number: M020 HealthyDerm tallow mineral sunscreen SPF50 ZINC OXIDE 25% VIRENTIA LLC 557b0b1f-8cd9-735a-e063-6294a90ad60e 2026-06-30 Warnings Exact identifier application number: M020 OHUI Ultimate Cover CC Cushion Compact 01 Light Beige TITANIUM DIOXIDE LG H&H Co., Ltd. d2f9c54b-ac4e-5141-e053-2a95a90aa2b8 2026-06-30 Warnings Exact identifier application number: M020 Christian Dior Invisible UV Stick Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Parfums Christian Dior 8e3840b2-b404-474f-aff7-dec3a64a70a4 2026-06-29 Warnings Exact identifier application number: M020 TOCOBO Blur Finish Sun Cushion Cotton Blue HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE PICTON Co., Ltd. 4d6ddee3-9a76-6c9c-e063-6394a90a1529 2026-06-29 Warnings Exact identifier application number: M020 Sun Bum Coconut Lip 30 Sunscreen Lip Balm AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 20d942fa-93de-45a8-e063-6294a90a2b49 2026-06-29 Warnings Exact identifier application number: M020 AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN ZINC OXIDE THE AVON COMPANY 54f7c1d1-acdb-fd25-e063-6294a90a8173 2026-06-29 Warnings Exact identifier application number: M020 Earth Baby Broad Spectrum SPF 30 SUNSCREEN Earth Baby, Inc. 42556876-74ea-38e6-e054-00144ff8d46c 2026-06-28 Warnings Exact identifier application number: M020 TOCOBO Cotton Airy Sun Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE PICTON CO., Ltd. 55364026-c55a-b370-e063-6294a90ae0d1 2026-06-27 Warnings Exact identifier application number: M020 Sun Does Matter Daily Face Sunscreen HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE Sundoesmatter Company Inc. 553687d8-d4e1-8361-e063-6294a90a24fe 2026-06-27 Warnings Exact identifier application number: M020 ORLASKIN HYDRATING SUNSCREEN SPF 50 OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONE Guangzhou Yapheon Health Industry Co., Ltd. 552b4c87-4621-d5a7-e063-6294a90a042e 2026-06-26 Warnings Exact identifier application number: M020 Bath and Body Works SPF Waikiki Beach Coconut AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 1c30de8a-4d29-bbac-e063-6294a90a84d9 2026-06-26 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