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 |
|---|---|---|---|---|---|---|
| Poolside Golden Hour SPF 15 Sunscreen Lip | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 7d0f8319-f0fa-4ea7-bb66-427c5a78145a | 2026-02-10 | Warnings | M020 |
| Tanri Broad Spectrum SPF 30 | SUNSCREEN | I. Shay Cosmetics | 26d5b9d1-d669-3430-e063-6394a90ad7f2 | 2026-02-10 | Warnings | M020 |
| DAILY SUNSCREEN BROAD SPECTRUM SPF 30 | ZINC OXIDE | S+ | 9d6ffe56-debc-4ad2-837b-fd7bb091a56f | 2026-02-09 | Warnings | M020 |
| Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | a9c970c8-b6e3-b0a1-e053-2a95a90a89c7 | 2026-02-09 | Warnings | M020 |
| Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face | ZINC OXIDE | Solavida, LLC | 4a694cdf-496b-3bc0-e063-6294a90af0d1 | 2026-02-09 | Warnings | M020 |
| numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BENOW BEAUTY INC | 32bfb17c-5535-c016-e063-6394a90a1814 | 2026-02-09 | Warnings | M020 |
| TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 4a6b69ed-2739-d22a-e063-6294a90a1e52 | 2026-02-09 | Warnings | M020 |
| SUNPLUS LIP LIFE | SUNSCREEN | I. Shay Cosmetics | 26d28286-e812-0fb3-e063-6394a90a338d | 2026-02-09 | Warnings | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | bb86322d-ff30-4a54-97b5-1be275067146 | 2026-02-06 | Warnings | M020 |
| Hampton Sun SPF 50 Mineral | ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00% | S&C Hampton Sun LLC | d6c33436-042e-44e8-8b55-98be6e246879 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO COLOR-SMART DAY MOISTURIZER | OCTINOXATE, TITANIUM DIOXIDE | Shiseido Americas Corporation | f291f077-1c72-48fc-bb19-c20bdeaaa596 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO SHIKULIME COLOR CONTROL | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Shiseido Americas Corporation | f225a736-2ff7-4084-88a4-a8df5b043cce | 2026-02-06 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | American Sales Company | 79dff6ec-d958-4bba-999b-da4aa67519f5 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate, Octocrylene | SUNSCREEN | Retail Business Services, LLC | 1dc325bb-d520-4897-b8f8-3f0ecba2274c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | d8a55217-ae50-4c7f-a440-f4de079d08ae | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | f2a4b432-118e-42a4-baeb-90614dccbd06 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 232ab407-1903-45d8-a2b2-6992ffd30d00 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 0ccef180-0eb1-cf2b-e063-6394a90adf0c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen for Kids SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 6a455f1a-4285-44c3-820a-85a50d1bbc5b | 2026-02-06 | Warnings | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 15bf22f5-a8f5-44bb-b787-2b762b330d61 | 2026-02-06 | Warnings, Adverse reactions | 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 |