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 42 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EltaMD UV Restore Tinted TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc. 6a48ad0d-20e4-44b1-90d6-30bfbc68a152 2026-04-17 Warnings Exact identifier application number: M020 Pacto Refreshing Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Mynd LLC 56ad7c97-3dae-4bac-a677-f5052dfdfea4 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f95cd0a-f996-648b-e063-6294a90adc28 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f968058-e851-86d0-e063-6294a90aa786 2026-04-16 Warnings Exact identifier application number: M020 Red Cherry SPF 15 Broad Spectrum Lip Balm RED CHERRY SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc 4f96d057-39b8-e4d5-e063-6394a90acb5c 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f970778-97d6-40a9-e063-6394a90a6c89 2026-04-16 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Fair-Light ZINC OXIDE ZO Skin Health, Inc. 4f9988a0-ae4a-9940-e063-6294a90ad91d 2026-04-16 Warnings Exact identifier application number: M020 MELAO Hydrating Mineral Sunscreen TITANIUM DIOXIDE,ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4f778eb0-55f7-38d0-e063-6394a90a69a0 2026-04-15 Warnings Exact identifier application number: M020 Tanning Club Everyday Sunscreen SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE TANNING CLUB, LLC 75820400-a5e0-4cf5-8b4f-a52500ce62c3 2026-04-15 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f81e482-8111-451c-e063-6294a90ad148 2026-04-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f8353b3-4ac1-9703-e063-6294a90abdad 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f83dd76-a8d8-916e-e063-6294a90ab6ed 2026-04-15 Warnings Exact identifier application number: M020 Mineral Sunscreen Stick - Tinted TITANIUM DIOXIDE, ZINC OXIDE UNDRBUDR, LLC 4f84619f-3415-7443-e063-6394a90a162a 2026-04-15 Warnings Exact identifier application number: M020 Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory TITANIUM DIOXIDE AND ZINC OXIDE PML NYC, LLC 1be639a8-179a-7015-e063-6394a90ab64b 2026-04-15 Warnings Exact identifier application number: M020 PHELITYL DAY SPF 15 PHELITYL DAY SPF 15 PML NYC, LLC ea9d33d9-6f9f-0a66-e053-2a95a90abd42 2026-04-15 Warnings Exact identifier application number: M020 FIRMARINE MOISTURIZER SPF 30 FIRMARINE MOISTURIZER SPF 30 PML NYC, LLC ea9db179-1b69-01e0-e053-2a95a90a1628 2026-04-15 Warnings Exact identifier application number: M020 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 EVEN TRUE NUTRITIVE SKIN MOISTURIZER SPF 15 PML NYC, LLC eaa562b1-3fc6-1a85-e053-2995a90ad1ec 2026-04-15 Warnings Exact identifier application number: M020 DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 PML NYC, LLC ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 2026-04-15 Warnings Exact identifier application number: M020 RICH GIRL HAND SPF 25 RICH GIRL HAND PML NYC, LLC ea8f4421-109f-41a5-e053-2a95a90a3832 2026-04-15 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e24a63e-d76f-6581-e063-6394a90a6181 2026-04-15 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