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 |
|---|---|---|---|---|---|---|
| Dr. C. Tuna Sun Stick SPF 50 | AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | fc89d1b5-1ffe-4f06-8c5c-31f2eb0b5641 | 2026-01-14 | Warnings | M020 |
| Oiana Mineral Sunscreen Drops | ZINC OXIDE | Oiana LLC | 4860257d-a8bf-7ce5-e063-6394a90a74db | 2026-01-14 | Warnings | M020 |
| Standard Procedure Lip Balm SPF 50 | ZINC OXIDE HOMOSALATE OCTOCRYLENE | Standard Procedure Inc | 1e3db995-b1c5-3a2e-e063-6294a90af75e | 2026-01-14 | Warnings | M020 |
| Standard Procedure SPF 50 Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Standard Procedure Inc | 1d3f87de-90c0-75c0-e063-6394a90a2ef4 | 2026-01-14 | Warnings | M020 |
| EELHOE Bio Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 48654406-505b-518b-e063-6394a90a5add | 2026-01-14 | Warnings | M020 |
| JAYSUING Hyaluronic Acid Moisturizing Sunscreen | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 48662fae-2d41-4a4a-e063-6394a90a1522 | 2026-01-14 | Warnings | M020 |
| CALIFORNIA ALOE FRESH POW DERY SUN | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | NATURE REPUBLIC CO., LTD. | aa10dbbf-97b3-4258-bbd3-0d8cc9935e12 | 2026-01-13 | Warnings | M020 |
| COSRX | VITAMIN E VITALIZING SUNSCREEN | COSRX inc. | 4840f608-944a-3e3d-e063-6394a90a1d9d | 2026-01-13 | Warnings | M020 |
| Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 Plus | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | b043f0f3-b263-4c49-86ca-9ecc71a22aa8 | 2026-01-13 | Warnings | M020 |
| ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30 | ZINC OXIDE | New Frontier Bio, Inc | ef6c8443-fd10-2022-e053-2a95a90a45ea | 2026-01-13 | Warnings | M020 |
| Bluevado Sunfix | ZINC OXIDE, TITANIUM DIOXIDE | Magic Blue, LLC | 2e5315bf-39f4-401c-8207-18ef6a97e024 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e20f5dc9-e863-b090-e053-2a95a90a5044 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical Clear SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | 1305fa94-47d5-7a42-e063-6394a90a0aba | 2026-01-13 | Warnings | M020 |
| Intellishade Clear SPF 50 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE | Revision, LLC | e213b46d-d061-dc83-e053-2995a90ad875 | 2026-01-13 | Warnings | M020 |
| Intellishade Matte SPF 45 | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e213ae87-4db2-3070-e053-2995a90a083b | 2026-01-13 | Warnings | M020 |
| Sun Project Moisture | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE | THANK YOU FARMER CO., LTD | 20a83f02-d851-4aac-e063-6394a90ae1a6 | 2026-01-13 | Warnings | M020 |
| THANK YOU FARMER Sun Project Soothing | HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | THANK YOU FARMER CO., LTD | 20a60051-d57c-a341-e063-6394a90a9243 | 2026-01-13 | Warnings | M020 |
| Sun Guard | ZINC OXIDE | Saje Natural Business Inc | 87ee593d-668c-f592-e053-2a95a90a17b1 | 2026-01-13 | Warnings | M020 |
| Vixin Beach Face Sunscreen SPF50 | ZINC OXIDE | Veganic SKN Limited | 482ae347-d175-52f2-e063-6394a90a92b0 | 2026-01-12 | Warnings | M020 |
| FRE Glow ME Lightweight Tinted Moisturizer | ZINC OXIDE | Peer Pharm Ltd | 1cf5b24a-e6fd-470a-e063-6294a90ab29c | 2026-01-12 | 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 |