STUDIO FIX FLUID SPF 15 BROAD SPECTRUM
- Product NDC
- 40046-0072
- 11-digit product format
- 400460072
- Labeler code
- 40046
- Product ID
- 40046-0072_2a15bb87-bf9d-336e-e063-6294a90a85f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE and TITANIUM DIOXIDE
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- MAKEUP ART COSMETICS
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-12-01
- Substance
- OCTINOXATE; TITANIUM DIOXIDE
- Active strength
- 25; 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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 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 | 40046-0072-0 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 40046-0072-9 | 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 | 40046-0072-0 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 40046-0072-9 | 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 | 40046-0072-0 | 27f29a85d7e4… | 1372111e901f… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 40046-0072-9 | 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 | 40046-0072-0 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 40046-0072-9 | 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 | 40046-0072-0 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 40046-0072-9 | 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 | 40046-0072-0 | 50b4072663b7… | eae3003ed65e… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 40046-0072-9 | 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 SPF 15 BROAD SPECTRUM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 25 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 |
|---|---|
| ff48435d-245a-4037-9afb-caee83c4c415 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0072-1 | 2022-08-04 | C162847 | 48780-1 | e4f33bdf-a796-d8a0-e053-dadaa90a6e4e | STUDIO FIX FLUID SPF 15 BROAD SPECTRUM |
| 40046-0072-1 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a796-d8a0-e053-dadaa90a6e4e | STUDIO FIX FLUID SPF 15 BROAD SPECTRUM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0072-1 | STUDIO FIX FLUID SPF 15 BROAD SPECTRUM | 30 mL in 1 BOTTLE | LIQUID | 30 | 10 | |
| 40046-0072-1 | STUDIO FIX FLUID SPF 15 BROAD SPECTRUM | 1 in 1 CARTON | LIQUID | 1 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0072 | STUDIO FIX FLUID SPF 15 BROAD SPECTRUM (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241227_ff48435d-245a-4037-9afb-caee83c4c415.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 |
|---|---|---|---|---|---|---|
| Ray Defense Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements | 807db1ff-a64a-44e4-a786-f88cd4518433 | 2025-12-17 | Warnings | M020 |
| SPF 50 Face Sunscreen Bioelements | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements, Inc | 981c7b3c-d7d6-483d-bf32-10d526be5b3f | 2025-12-17 | Warnings | M020 |
| Glow Oil SPF 50 Beach Flower | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | 2a46d7d2-293f-5024-e063-6294a90a31aa | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f114022-daaa-1834-e063-6394a90afd1d | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f113048-adfb-7d2a-e063-6294a90a2012 | 2025-12-17 | Warnings | M020 |
| Coppertone Oil Free and Shine Control Face Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | f3d163b4-6774-4c2e-e053-2a95a90afd59 | 2025-12-17 | Warnings | M020 |
| Coppertone EveryTone Face Sunscreen SPF 55 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b12f39-778c-ecee-e063-6394a90afa24 | 2025-12-17 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Fair Cool | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 462e9a4a-ef28-0e0e-e063-6394a90ab4f8 | 2025-12-17 | Warnings | M020 |
| Mattifying Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | b27d7df0-3c84-4cc5-9ef3-07105311fed9 | 2025-12-17 | Warnings | M020 |
| Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Galderma Laboratories, L.P. | 45d101be-2b88-4759-9ccc-556f5ec0553d | 2025-12-17 | Warnings | M020 |
| Brightening Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | a42d6761-47cd-4c9b-9656-64e37e065639 | 2025-12-17 | Warnings | M020 |
| Avail Body with Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Emeis Cosmetics Pty Ltd | 4bb39ea1-f948-4357-b425-0cafd454ce30 | 2025-12-17 | Warnings | M020 |
| Bronzing Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f749af07-0fcd-4376-be62-7c078b3e7eb6 | 2025-12-17 | Warnings | M020 |
| Miffy Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 98a2906d-61e2-4627-a695-a20f10872f9a | 2025-12-16 | Warnings | M020 |
| Dear Sun Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 80748647-e0ea-46dc-8ee2-a0ad77c4b19d | 2025-12-16 | Warnings | M020 |
| SUNSCREEN Stick | ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 460e1038-30f0-a6e4-e063-6394a90ad534 | 2025-12-16 | Warnings | M020 |
| SUNSCREEN SPRAY150ml | ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 460ead6c-dd44-e320-e063-6294a90a2b64 | 2025-12-16 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5% | Foshan Sugar Max Cosmetics CO.,Ltd | 460f0ca0-9440-9a6e-e063-6394a90a33b3 | 2025-12-16 | Warnings | M020 |
| Unseen Sunscreen Lip Protector SPF 30 | OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE | Supergoop LLC | db12a89f-5fef-1b2a-e053-2a95a90a56f9 | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365f3c48-15a6-2d32-e063-6394a90aad78 | 2025-12-16 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 40046-0072-1 | 40046007201 | 1 BOTTLE in 1 CARTON (40046-0072-1) / 30 mL in 1 BOTTLE | 1 bottle | 2005-12-01 | 0000-00-00 | No | No | Current |