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 2026-10-15 unfinished package package 40046-0082 40046-0082-0 UNFINISHED Active or certified unfinished drug listing 2026-10-15
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 6 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 CORBY, JR., TERRY L. 594443fd-8e27-4ec6-e063-6294a90a3ff0 2026-08-17 Warnings Exact identifier application number: M020 Meraki Protective Mist Sunscreen BROAD SPECTRUM SPF 30 MERAKI MEDICAL SPA LLC 59446224-0e97-ae2c-e063-6394a90a2a65 2026-08-17 Warnings Exact identifier application number: M020 Sun Zapper - Acne Pure Zinc Sunscreen SPF50 ZINC OXIDE Veganic SKN Limited 3ee435a5-70fb-0c8a-e063-6394a90a650a 2026-08-16 Warnings Exact identifier application number: M020 Sun Zapper - Anti-ageing pure zinc sunscreen SPF30 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 3f1dc3b2-c289-5996-e063-6394a90ac622 2026-08-16 Warnings Exact identifier application number: M020 ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN ZINC OXIDE ISNTREE Inc. 58e38665-0bca-fb02-e063-6394a90ad62a 2026-08-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d3d390-8b88-a6fe-e063-6394a90a9bf8 2026-08-12 Warnings Exact identifier application number: M020 Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60 AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE Kenvue Brands LLC 58d7a3e3-b7df-43ce-e063-6294a90a729c 2026-08-12 Warnings Exact identifier application number: M020 HEB 50 Marigold Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 58dafa24-24d5-aeb4-e063-6394a90a3c25 2026-08-12 Warnings Exact identifier application number: M020 TESALOVA Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Tesalova Viktoriia PMU LLC 58dbb9f1-cfb3-62ac-e063-6394a90a6106 2026-08-12 Warnings Exact identifier application number: M020 Elta MD Skincare UV Stick Broad Spectrum SPF50 ZINC OXIDE CP Skin Health Group, Inc 58dd81db-46d4-d763-e063-6394a90abb0b 2026-08-12 Warnings Exact identifier application number: M020 Basin Coconut SPF 30 Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 4a8e93a6-dcf9-3687-e063-6394a90a73ac 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 Red Correcting ZINC OXIDE CP Skin Health Group, Inc. 26e63890-d1af-d171-e063-6394a90af828 2026-08-12 Warnings Exact identifier application number: M020 UV Skin Recovery SPF 50 ZINC OXIDE CP Skin Health Group, Inc. 26d2683f-cfd5-50fd-e063-6394a90a7576 2026-08-12 Warnings Exact identifier application number: M020 doTERRA Sun Body MINERAL SUNSCREEN doTERRA International, LLC 58dcc56f-f093-469c-e063-6394a90a6088 2026-08-12 Warnings Exact identifier application number: M020 Sonage Protec Plus SPF 30 Mineral Sunscreen ZINC OXIDE ASA Universal Inc. dba: Sonage d92fc1df-bbeb-592a-e053-2a95a90a6951 2026-08-12 Warnings Exact identifier application number: M020 Colorescience Total Protection Body Shield Glow ZINC OXIDE Colorescience 52e1d987-a4f8-195e-e063-6294a90a5629 2026-08-11 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 DR. SAMRAO'S OFFICE 58b2ca35-11ed-d848-e063-6294a90a5b37 2026-08-11 Warnings Exact identifier application number: M020 Ciele Tint and Protect ZINC OXIDE Ciele 0162d9c9-07fa-9210-e063-6294a90aa687 2026-08-11 Warnings Exact identifier application number: M020 NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 8e4b9c08-b906-4c5f-a243-55838ae28b90 2026-08-10 Warnings Exact identifier application number: M020 Sunscreen for Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE The Kroger Co. 1c7cd904-ffff-48aa-91bd-cc978946b36a 2026-08-10 Warnings, Adverse reactions 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