Cream
- Product NDC
- 61354-084
- 11-digit product format
- 613540084
- Labeler code
- 61354
- Product ID
- 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Titanium Dioxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-30
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 5 mg/100mg; mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|
| excluded product | product | 61354-084 | I | Inactivated by FDA | 2026-10-23 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-23 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61354-084-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61354-084-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61354-084-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-084-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-62bf-d83d-e063-dadaa90ab31f | TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-084-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | 1 | |
| 61354-084-01 | Cream | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Dolce and Gabbana Everlast Foundation SPF 20 22N Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | ad8afa83-2844-422c-b2bf-b5a61be368b1 | 2025-08-11 | Warnings | M020 |
| ScarAid SPF | SILICONE STICK WITH SPF | Biodermis, LLC | 3c19063a-cdde-1bbe-e063-6294a90aa8a2 | 2025-08-11 | Warnings | M020 |
| Pro-Sil SPF | SILICONE STICK WITH SPF | Biodermis, LLC | 3be06f82-935d-b1c2-e063-6294a90a953c | 2025-08-11 | Warnings | M020 |
| Curology Daily Moisturizing | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | Curology, Inc | 3c1967fc-bb89-2f7e-e063-6394a90a2512 | 2025-08-11 | Warnings | M020 |
| ScarAid US SPF | SILICONE STICK WITH SPF | Biodermis, LLC | 3c196fa4-1bd3-7a43-e063-6294a90a4fb7 | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 23W Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 96973dee-681b-4c5d-b31f-de05cd79fa18 | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 24N Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | ecda3658-eca1-48c2-9eff-e22fd1ff70df | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3 | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 968abacd-8b99-4529-a627-2b56cdf99e1b | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | a9068dc0-bc48-498b-adc9-57ff810384af | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 37f01f66-c604-4fc3-a263-2089db91283f | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | bca57893-bd2d-44ac-a503-2f11c3b62bf2 | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 37188b77-ab0b-4bea-b839-99e589600a2b | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | c89e45d6-2322-4913-a557-e1780a86fd63 | 2025-08-11 | Warnings | M020 |
| Sun Bum Face 70 Premium Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 3c1ed89c-6d50-6400-e063-6294a90a1433 | 2025-08-11 | Warnings | M020 |
| NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50 | ZINC OXIDE | NAKED SUNDAYS PTY LTD | 24e9ea4d-3073-c126-e063-6394a90a7c6e | 2025-08-10 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | d1c5b7a5-73f9-4df6-9469-ce42e4f33ae8 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 96efeb92-a276-4ac9-b30a-11b4fa367263 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER PEACH SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | edeb2ee1-cc84-4254-80c1-6410cd77c422 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER STRAWBERRY SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 7abe936b-a4d5-457c-9cdd-761b201bb046 | 2025-08-08 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-084-01 | 61354008401 | 1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE | 1 tube | 2022-08-30 | 0000-00-00 | No | No | Current |