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 |
|---|---|---|---|---|---|---|
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228fab45-e0d2-f219-e063-6294a90a1ef6 | 2026-01-05 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228055ec-ff59-4412-e063-6394a90abe14 | 2026-01-05 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 236bdb53-d7a5-43a2-8a0c-bce4a5522e26 | 2026-01-05 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 4bd99626-690b-49e8-8c42-a2e2dbca09bf | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE LONG-LASTING HYDRATING VEIL | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f04ece6c-66b6-48e9-8f6b-e898a538ba00 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N I10 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 05ffb157-5e28-4e94-866d-9e3371480d84 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CONCEALER N 1 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | eedf8065-8897-4773-9cbb-bab57d2dd04f | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE BRIGHTENING ENHANCER VEIL | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | beefe840-6f32-483b-8a37-2696adb8eea1 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | addd9885-362c-4ce0-9a6e-759e71d8756c | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 65ca1240-6ee8-40c0-b62f-3597e0872c6e | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CORRECTING VEIL n M | ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 15a258a0-61c3-4419-bcdb-a8197d5ae46f | 2026-01-05 | Warnings | M020 |
| Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H Co.,Ltd. | 098c0a9b-2b96-6be3-e063-6294a90a959a | 2026-01-05 | Warnings | M020 |
| Poolside Butter Screen SPF 30 Sunscreen Butter | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ae838725-79ab-4c17-905b-d4138ad6af1f | 2026-01-05 | Warnings | M020 |
| Poolside Bronze Service Instant Bronzing Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | I World LLC | b98a9cec-3c48-4614-b091-4e59fa7d196e | 2026-01-05 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen Oil Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 5a9f8888-529d-40d7-9489-baa5ff657cb4 | 2026-01-05 | Warnings | M020 |
| Yon-Ka 50 Mineral Fluid | ZINC OXIDE | Laboratoire MULTALER Yon-Ka | 47a8c8b2-30ff-0d40-e063-6294a90ac461 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E | OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc | 2026-01-05 | Warnings | M020 |
| SHISEIDO SPORTS BB LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 260a3eab-8fe6-4259-8dcc-3706ca1f6881 | 2026-01-05 | Warnings | M020 |
| SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE | SHISEIDO AMERICAS CORPORATION | 4a16dbb7-e860-4aae-8e8b-67abbe8295bd | 2026-01-05 | Warnings | 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 |