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.
| 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.
| 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 |
|---|---|
| OCTINOXATE | 30 mg/mL |
| TITANIUM DIOXIDE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fb59afc1-1dc9-f783-e053-6394a90a196b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sport Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 6d1ad14e-afc6-4676-87d7-3e50e3a02fe9 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen for Babies SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 64766ed9-bd47-498d-bf59-fb30a7bf7e89 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | ccb651f6-e567-4c5f-9109-8767270cc4be | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 80dcd255-3a6c-4b79-b081-519c9dac990a | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Moisturizing Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Service, LLC | 9de8b6b1-024b-4b71-96e6-fea68088d3ab | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen | SUNSCREEN | Retail Business Services, LLC | 96221c10-ebfe-4385-b6b5-d504258df36c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Moisturizing Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | e2adbde9-3c8b-45f3-b4ef-4936b88d812d | 2026-02-06 | Warnings, Adverse reactions | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | bf1a237b-b27e-4c55-8ded-e348240a5b9a | 2026-02-06 | Warnings | M020 |
| SEYTU Body Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Omnilife USA, Inc. | c411e9a6-b2ea-446b-a886-b92c61736e6c | 2026-02-05 | Warnings | M020 |
| SEYTU Facial Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Omnilife USA, Inc. | 96fd37fb-c3ff-413f-b2c8-50754f320ecc | 2026-02-05 | Warnings | M020 |
| Sun Veil IlluminatingElixir Face Sunscreen SPF 38 | OCTISALATE, OCTOCRYLENE, ZINC OXIDE | Koco Life LLC | 4a15c479-d676-9e52-e063-6394a90a4eb4 | 2026-02-05 | Warnings | M020 |
| Golden Sunglaze Sheer Body Mist Sunscreen SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Koco Life LLC | 22d0a5db-6af1-a3ca-e063-6394a90a68ef | 2026-02-05 | Warnings | M020 |
| Sunglaze Sheer Setting Mist Sunscreen SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENE | Koco Life LLC | 22ce9b26-2bf8-c1ea-e063-6394a90a8ec2 | 2026-02-05 | Warnings | M020 |
| Peppermint SPF 15 Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Naples Soap Company, Inc. | 24adffd4-5177-f5d5-e063-6294a90a7850 | 2026-02-05 | Warnings | M020 |
| No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo | OCTINOXATE, TITANIUM DIOXIDE | BCM Cosmetique SAS | ebfe03e7-614f-44b1-b1f1-78edc7e274cc | 2026-02-05 | Warnings | M020 |
| Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30 | AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE | Flageoli Limited | 66f29201-6cbe-46d0-b54c-005a1ecefac4 | 2026-02-04 | Warnings | M020 |
| Tanning Club Mineral Sunscreen SPF 30 | ZINC OXIDE | Tanning Club LLC | d674ccbc-7bae-435c-a531-a79e569e69a9 | 2026-02-04 | Warnings | M020 |
| Derma B Everyday Fit Sunscreen SPF 50 | AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | NeoPharm Co., Ltd. | ba38a43d-7a8a-4814-ba34-0e99124f5fca | 2026-02-04 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42 | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 86630e82-f249-4866-82dd-3e21feb266c4 | 2026-02-04 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 42adc51f-f500-485d-82a0-126672141262 | 2026-02-04 | Warnings | M020 |
Packages#
| 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 |