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 52 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c500e58f-38b0-454e-8923-912844276b17 2026-03-20 Warnings Exact identifier application number: M020 Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZER TITANIUM DIOXIDE, ZINC OXIDE HEALTHY SKIN LAB LIMITED 4a1ec566-549f-45f2-a43d-dacfc7263361 2026-03-20 Warnings Exact identifier application number: M020 SOJO sunscreen ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d44efb6-abc5-c346-e063-6394a90a6023 2026-03-19 Warnings Exact identifier application number: M020 VRC Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d588fbe-e61a-2264-e063-6394a90aa060 2026-03-19 Warnings Exact identifier application number: M020 SOjO Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d5ed865-fff2-ee44-e063-6294a90a67e2 2026-03-19 Warnings Exact identifier application number: M020 ActivDerm Radiant Shield Broad Spectrum SPF 40 ZINC OXIDE ACTIVDERM LLC 4d6307f1-bab6-5f44-e063-6294a90a8e36 2026-03-19 Warnings Exact identifier application number: M020 Mad Robbit DEFEND SPF30 SUNSCREEN MAD RABBIT TATTOO, INC. bf853d54-ecd9-40cc-9f10-cb546bfb8933 2026-03-19 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 SKNVcare, LLC 4d67dfb4-3607-2af6-e063-6294a90ae01a 2026-03-19 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d3a36b9-7d60-01ac-e063-6294a90af4fb 2026-03-18 Warnings Exact identifier application number: M020 GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN ZINC OXIDE CLIO COSMETICS Co., Ltd. c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e 2026-03-18 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLE ZINC OXIDE COSMAX USA 4d318f51-1a43-44d5-e063-6394a90a4970 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVE ZINC OXIDE COSMAX USA 4d319110-e6a4-1ad3-e063-6394a90aa99c 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORAL ZINC OXIDE COSMAX USA 4d31b201-9d6a-730a-e063-6394a90a6700 2026-03-17 Warnings Exact identifier application number: M020 OSKIN New York Coffee BB Cream SPF 30 TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE O'Skin Studio NY 29dae75a-4368-432a-9cf8-f0f021f09e29 2026-03-17 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d39b64c-2e27-afed-e063-6394a90a3812 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d39ed7a-ca80-893c-e063-6294a90a03e7 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d3a0a92-b0de-a1ea-e063-6294a90a8508 2026-03-17 Warnings Exact identifier application number: M020 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Trader Joe's Company 4d3a36b9-7d63-01ac-e063-6294a90af4fb 2026-03-17 Warnings, Adverse reactions Exact identifier application number: M020 Redneck SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Redneck Sunscreen LLC 4d3a460b-1b98-2906-e063-6294a90a3669 2026-03-17 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 SKNVCARE, LLC 4d3ad051-3729-06fd-e063-6394a90ad0fe 2026-03-17 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