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 | 2026-10-28 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-28 |
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 |
|---|---|---|---|---|---|---|
| CVS Health 60 Plus Sensitive Skin Sun | TITANIUM DIOXIDE, ZINC OXIDE | CVS Pharmacy | 477c25ec-33db-04a6-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb75945-9d65-55b4-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 50 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6384a-8faf-5712-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 30 Clear | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6b50b-5236-6f5b-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Pharmacy SPF 70 Beach Guard Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4ec75d23-a33b-6c52-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Beach Guard Sun | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4adbd66a-6b38-046d-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 100 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 651c245c-2d3a-0019-e053-2991aa0a4637 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Sun | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 63b420ba-ac69-5670-e053-2a91aa0a864b | 2024-10-22 | Warnings | M020 |
| CVS Health Ultra Sheer SPF 100 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS PHARMACY | c52a7e9b-5401-f6e7-e053-2995a90a9519 | 2024-10-22 | Warnings | M020 |
| CVS Health Ultra Sheer Broad Spectrum SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | c68c3d6a-b656-abaf-e053-2a95a90a48db | 2024-10-22 | Warnings | M020 |
| CVS Health Ultra Sheer Broad Spectrum SPF 45 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | c5e8fcc9-db5c-9ee7-e053-2a95a90ac940 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 55 Ultra Sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | c617cdec-b489-22d2-e053-2995a90a1ec6 | 2024-10-22 | Warnings | M020 |
| TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 1b7c2f13-81b8-7af5-e063-6294a90a3501 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 50 Beach Guard | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | df25c35d-6b6d-1ef8-e053-2995a90aaef5 | 2024-10-22 | Warnings | M020 |
| CVS Health Kids SPF 50 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | e4581d0e-ce6d-7898-e053-2a95a90a02b5 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 55 Ultra Sheer Face Mist | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | dfb55b46-e88f-4949-e053-2995a90adabc | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 30 Clear Broad Spectrum | AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE | CVS PHARMACY | e4589114-87c5-56b8-e053-2995a90a0934 | 2024-10-22 | Warnings | M020 |
| TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15 | OCTINOXATE, ZINC OXIDE | Trader Joe's Company | a6805675-916c-4a19-b993-d465fcef58a1 | 2024-10-22 | Warnings | M020 |
| TRADER JOES FACE AND BODY SUNSCREEN SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 057ac99c-60e8-47c1-a32d-984bbd181846 | 2024-10-22 | Warnings | M020 |
| TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30 | ZINC OXIDE | Trader Joe's Company | 9e48de83-cb72-4c03-a819-939db8793e1f | 2024-10-22 | 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 |