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 73 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 310a07bb-d32a-401f-955e-4c2860148a30 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 39ae4a97-7f96-4c95-a6de-0c779764fb02 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc3e-055c-e51d-e063-6294a90a00f5 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 9c7a31df-5bdd-403b-b807-1d1a801e1bb6 2026-01-20 Warnings Exact identifier application number: M020 Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One ZINC OXIDE Clean Beauty For All, Inc (dba Saie) 1922fc51-ae53-acb8-e063-6394a90a14eb 2026-01-20 Warnings Exact identifier application number: M020 Wrinkle Repair Moisturizer SPF 30 EQB AVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2% Walmart a067e968-e598-40ef-95f2-c338b5e413dd 2026-01-20 Warnings Exact identifier application number: M020 Welmedix HomeCare PRO Fragile Skin Dual Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Welmedix LLC 48da4589-0f5a-c25b-e063-6394a90ac18b 2026-01-20 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Kids ZINC OXIDE 14.69% S&C Hampton Sun LLC 0bdb7d15-dc52-4e23-9417-fe73f17f6110 2026-01-20 Warnings Exact identifier application number: M020 DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICK OCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATE DEWYTREE CO. ,LTD 48406e68-eefd-d2c2-e063-6394a90a4ad9 2026-01-20 Warnings Exact identifier application number: M020 KONEUK SUNSCREEN SPF50 KONEUK SUNSCREEN SPF50 Guangzhou Meixi Biotechnology Co., Ltd. 48dd7f6e-2a4d-2c92-e063-6294a90a4255 2026-01-20 Warnings Exact identifier application number: M020 CHUDA AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE Premier Ocher LLC 1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f 2026-01-20 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 12edec55-2414-4bbd-bc96-4599a96b96ac 2026-01-19 Warnings Exact identifier application number: M020 PROJECT REEF SPF-30 Mineral Sunscreen ZINC OXIDE Project Reef LLC a6077e6f-d987-4159-946f-3e2397247659 2026-01-19 Warnings Exact identifier application number: M020 OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE Coral Reef Park Co., Inc. 86ee2fdf-8a88-44e6-b12a-36a92360477a 2026-01-19 Warnings Exact identifier application number: M020 SABAL Mineral Sunscreen Broad Sprectrum SPF 30 ZINC OXIDE SABAL SUN LLC f917b446-4e10-4231-826e-fdac32e11186 2026-01-19 Warnings Exact identifier application number: M020 Plius Daily SPF Moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE PLIUS, Inc 31866de9-afa0-4c11-be65-b61373551493 2026-01-19 Warnings Exact identifier application number: M020 PROTEKT SPF-50 Sheer Mineral Sunscreen ZINC OXIDE Protekt Products, Inc. 6edc0941-bb21-4797-a875-81f727694774 2026-01-19 Warnings Exact identifier application number: M020 Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21) ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20% Grace and Fire USA Inc. 48c1b93c-9c6f-95aa-e063-6294a90a0cfa 2026-01-19 Warnings Exact identifier application number: M020 ANUA INVISIBLE GLOW FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 446ac344-1078-4cd1-e063-6294a90a4bd4 2026-01-19 Warnings Exact identifier application number: M020 ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 31af7b5e-2bd6-63ee-e063-6294a90a0806 2026-01-19 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