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 49 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sunscreen Cream AVOBENZONE, OCTISALATE, OCTOCRYLENE Jiangsu Senwo Medical Technology Co., Ltd. 4e615757-76b1-8f34-e063-6394a90a280a 2026-04-01 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Sunstick SPF 30 ZINC OXIDE Elemental Herbs, Inc. 4e67b76e-b791-4e26-e063-6294a90aa991 2026-04-01 Warnings Exact identifier application number: M020 All Good Coconut Mineral Sunscreen Sunstick SPF 30 ZINC OXIDE Elemental Herbs, Inc. 4e67e89b-a7be-a540-e063-6294a90a6d8f 2026-04-01 Warnings Exact identifier application number: M020 SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Shiseido Americas Corporation cad3a446-36a8-4146-81b5-1cc8d65abf14 2026-04-01 Warnings Exact identifier application number: M020 MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Forest Avenue Co., Ltd. 8de4ec46-f60a-4c51-a16e-9140150e2162 2026-04-01 Warnings Exact identifier application number: M020 ChapStick Moisturizer Cool Mint SPF 15 SPF 15 LIP PROTECTANT Suave Brands Co., LLC 42f50497-ded1-6863-e063-6294a90a39c8 2026-03-31 Warnings Exact identifier application number: M020 Purito Sunday Adventure Sunscreen SPF 50, 50 mL AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hinature bf16f535-97fc-4fd8-9310-8b6bbc82baae 2026-03-31 Warnings Exact identifier application number: M020 spf 50 mineral powder sunscreen TITANIUM DIOXIDE, ZINC OXIDE Smalls Brand LLC DBA Roe Wellness f8762dd1-0484-74ea-e053-6294a90ac112 2026-03-31 Warnings Exact identifier application number: M020 Badger SPF 30 Face Mineral Sunscreen ZINC OXIDE W.S. Badger Company, Inc. 14a9b605-f1f0-00e5-e063-6394a90a5a51 2026-03-31 Warnings Exact identifier application number: M020 Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades) OCTINOXATE AND ZINC OXIDE Noxell Corporation 38bba282-b4f7-4374-8732-419400b1cc50 2026-03-31 Warnings Exact identifier application number: M020 SeranovaTM ULTRALIGHT SPF50 SERUM SERANOVATM ULTRALIGHT SPF50 SERUM Guangzhou Ariel Biotech Co., Ltd. 4e5d716d-2b2d-d42f-e063-6294a90a1e52 2026-03-31 Warnings Exact identifier application number: M020 ageLOC Tru Face Radiant Day AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE NSE Products, Inc. 3e9a0b39-4351-41df-81b2-88c1c15c0db2 2026-03-31 Warnings Exact identifier application number: M020 Sunright Solar Screen Mineral Face Sunscreen ZINC OXIDE NSE Products, Inc. 93a32040-3a47-4d6f-baa1-5a4595bef410 2026-03-31 Warnings Exact identifier application number: M020 Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day AVOBENZONE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc 28f500e2-41d1-4747-8f26-3f6f8cc1b583 2026-03-30 Warnings Exact identifier application number: M020 Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance Day AVOBENZONE, OCTISALATE, AND OCTOCRYLENE SICOS ET CIE dd448b7a-2554-4dfc-9eb3-ec3486ec6197 2026-03-30 Warnings Exact identifier application number: M020 ANUA MINERAL WEIGHTLESS FINISH SUNSCREEN ZINC OXIDE Thefounders 4e37d291-84fb-252a-e063-6294a90acd1f 2026-03-30 Warnings Exact identifier application number: M020 Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE THE AVON COMPANY 4e43bea2-247d-fe11-e063-6294a90a33a3 2026-03-30 Warnings Exact identifier application number: M020 Abib Quick sunstick Protection bar HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE FOURCOMPANY CO., LTD. 1a2ab632-643f-1aa9-e063-6394a90a0c05 2026-03-30 Warnings Exact identifier application number: M020 ChapStick Classic Original Military SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4514490b-f348-4526-e063-6294a90ad505 2026-03-30 Warnings Exact identifier application number: M020 ChapStick Moisturizer Black Cherry SPF 15 SPF 15 SKIN PROTECTANT Suave Brands Co., LLC 42f40978-51ca-f448-e063-6294a90acf31 2026-03-30 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