Home NDC 40046-0082-0 STUDIO FIX FLUID BROAD SPECTRUM SPF 15
Product NDC 40046-0082
Requested package NDC 40046-0082-0
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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
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 1 of 359 · 7,165 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 8e4b9c08-b906-4c5f-a243-55838ae28b90 2026-07-29 Warnings Exact identifier application number: M020 Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, AND OCTISALATE NeoStrata Company Inc. 4739e678-ce51-4863-bb74-2275879e1b47 2026-07-29 Warnings Exact identifier application number: M020 MELAO GHK-Cu PEPTIDE SUNSCREEN BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE Guangdong Aimu Biological Technology Co., Ltd 57a8c34a-d6c9-c03e-e063-6394a90a7af1 2026-07-29 Warnings Exact identifier application number: M020 BelleJoss BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c07f29-2e23-d18a-e063-6394a90a1020 2026-07-29 Warnings Exact identifier application number: M020 BemeJolie BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c27cea-bb0c-5d2d-e063-6394a90a1b48 2026-07-29 Warnings Exact identifier application number: M020 Native Mineral Suncare Broad Spectrum SPF 30 Unscented ZINC OXIDE The Procter & Gamble Manufacturing Company 3a89238b-d1ee-d7fa-e063-6294a90ae55f 2026-07-28 Warnings Exact identifier application number: M020 First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company dfb1b42e-c821-1a41-e053-2995a90acf95 2026-07-28 Warnings Exact identifier application number: M020 LUXE COLOR FOUNDATION OCTINOXATE 7% ZINC OXIDE 5% Guangzhou Huixue Biotechnology Co., Ltd. 576c3496-702f-808c-e063-6394a90a53c3 2026-07-25 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Xact Packing Limited 5759058d-e683-f3fc-e063-6394a90abc01 2026-07-24 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT ZINC OXIDE Younique, LLC f93d42a9-b655-4b75-a16d-b29f38f04efc 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM ZINC OXIDE Younique, LLC 82769819-b229-4864-9b3c-44f49a68a53a 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR ZINC OXIDE Younique, LLC ed700cae-8226-48d9-93ba-03154aa1cae5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT ZINC OXIDE Younique, LLC d728b89c-692f-485b-88c3-929b2f0350d5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM ZINC OXIDE Younique, LLC a49dfff1-e9ec-4573-90b0-ef6a7226aa56 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK ZINC OXIDE Younique, LLC cc576b63-caf4-491d-8d7f-027b1127133b 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK ZINC OXIDE Younique, LLC 2173666b-6c72-449d-9f40-098ea174f3e1 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEP ZINC OXIDE Younique, LLC 360ceb90-bec6-4fec-820a-a4d65008b872 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEP ZINC OXIDE Younique, LLC 86c33a9e-9132-4377-8688-41e5844de62c 2026-07-23 Warnings Exact identifier application number: M020 MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTURE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Forest Avenue Co., Ltd. edbfcf21-96c6-4519-8b08-f9b5ada7d1d7 2026-07-23 Warnings Exact identifier application number: M020 SKINSUIT LIP SPF 30 ZINC OXIDE Skin Authority LLC cb24d714-f6cd-4518-b146-627cfe6c2ccd 2026-07-23 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 40046-0082-0 40046008200 180 mL in 1 BOTTLE (40046-0082-0) 180 ml 21-NOV-23 Current