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 74 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ANUA INVISIBLE MATTE FINISH SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Founders Inc. 4248deaf-ad55-a9b4-e063-6294a90a55cc 2026-01-19 Warnings Exact identifier application number: M020 ONSART Mineral Sunscreen ZINC OXIDE 24% Guangzhou Huixue Biotechnology Co., Ltd. 48c9d08d-9a91-7df5-e063-6294a90a1c4a 2026-01-19 Warnings Exact identifier application number: M020 Intense Moisture Day Cream AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE CVS Health 795d3546-f0dd-4b54-9807-9cdb3e626181 2026-01-19 Warnings Exact identifier application number: M020 CURESHIELD MANICURE SUNSCREEN ZINC OXIDE, TITANIUM DIOXIDE GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD 48b4fad7-073d-d983-e063-6394a90ae314 2026-01-18 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 65ff0448-17e6-42ce-989a-940794fcbd8c 2026-01-17 Warnings Exact identifier application number: M020 BenzoAzeline 10 BENZOYL PEROXIDE Noon Aesthetics M.R. Ltd 985efa19-bd91-45cd-a2a0-d71ec325e51c 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Berry SPF 30 PREQUEL LIP VISOR BERRY SPF 30 The Center Brands, LLC e4f3a0eb-4a8c-4145-92e4-979f03e3a511 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Blush SPF 30 PREQUEL LIP VISOR BLUSH SPF 30 The Center Brands, LLC bc681245-e158-4cfa-9718-7ec4cff0e60d 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Mahogany SPF 30 PREQUEL LIP VISOR MAHOGANY SPF 30 The Center Brands, LLC ea8dcd14-3c54-46a6-aabc-3655f051065b 2026-01-16 Warnings Exact identifier application number: M020 Prequel Lip Visor Nude SPF 30 PREQUEL LIP VISOR NUDE SPF 30 The Center Brands, LLC 03a7c77d-7b6e-4720-88f1-492ce57c7145 2026-01-16 Warnings Exact identifier application number: M020 Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30 ZINC OXIDE CVL Cosmetics North America Inc f3057856-1461-41d3-a5c4-9f12e3a4a0ee 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 04e9c4d8-1600-4ffc-8578-4ffb82b106f3 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 1aae19da-1e73-41ed-91dc-0746ad311b87 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 22d4452d-3798-48c6-a7a4-4af0f99b4ebd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior d6800bb7-16ef-48f6-a09a-0422e64ad8bd 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior fb9cfd4f-a558-4df2-bbbf-b814ae19a135 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b9ddcda6-3d87-4197-a2c2-5b30016d32eb 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 25abef37-1726-491f-8a11-ac1a96378ed1 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b0e315b3-a322-4607-b212-bcadd5aa99bc 2026-01-16 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