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 | 2026-10-27 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| SPF 50 Sunscreen Unfragranced | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | 05e4706b-1955-aba8-e063-6294a90a29c7 | 2024-12-19 | Warnings | M020 |
| Rubber Ducky SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | cf32b3a0-de88-b866-e053-2a95a90a3f32 | 2024-12-19 | Warnings | M020 |
| SPF 50 Sunscreen Rocky Mountain | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | a216d48f-4ed4-6008-e053-2a95a90a8c9a | 2024-12-19 | Warnings | M020 |
| Rod and Rifle SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | fc61847b-cb61-97b1-e053-6394a90ae1b9 | 2024-12-19 | Warnings | M020 |
| Habana Brisa SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | db0d6dec-d0ee-6160-e053-2a95a90a2c6e | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Derma Care Research Labs, LLC | f8730f9c-43c1-f4d3-e053-6294a90a1809 | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f8735925-dcb2-6723-e053-6294a90a51f4 | 2024-12-19 | Warnings | M020 |
| Caribbean Breeze SPF 70 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f873c125-86b8-3d1d-e053-6394a90a6bcf | 2024-12-19 | Warnings | M020 |
| Royal Boost Cover Me Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | efd7d887-0616-4c76-84d8-5370eb63cb7f | 2024-12-19 | Warnings | M020 |
| Rubber Ducky SPF 50 Unfragranced Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Derma Care Research Labs, LLC | 043b447c-4519-37ce-e063-6394a90a7197 | 2024-12-19 | Warnings | M020 |
| Australian Sands SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | f886a02f-c043-b281-e053-6294a90af746 | 2024-12-19 | Warnings | M020 |
| SPF 50 Sunscreen Rocky Mountain | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Derma Care Research Labs, LLC | a1c9066c-4801-5aee-e053-2995a90a75d2 | 2024-12-19 | Warnings | M020 |
| Dr. Throwers SPF 30 Face and Body Sunscreen | AVOBENZONE 3%, HOMOSALATE 12%, OCTISALATE 5%, OCTOCRYLENE 3% | Derma Care Research Labs, LLC | d680b6f6-e1a9-47a4-e053-2a95a90ae3b0 | 2024-12-19 | Warnings | M020 |
| Vacation Broad Spectrum SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Vacation Inc. | 29a7636c-4d99-2cac-e063-6394a90a7480 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMEL | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 29a82ba9-c0f8-0edf-e063-6294a90a50b4 | 2024-12-19 | Warnings | M020 |
| Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SABLE | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, INC | 29a8812b-70ff-e8aa-e063-6294a90a09f8 | 2024-12-19 | Warnings | M020 |
| CLE CCC Neutral Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE | KW ABSC, INC. | 3a548deb-3670-4c5b-a139-796701801fed | 2024-12-19 | Warnings | M020 |
| CLE CCC Olive Medium Deep | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | be4434c0-cbdd-46cb-8015-4c7859e80d4a | 2024-12-19 | Warnings | M020 |
| CLE CCC Golden Medium | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | de50e956-a014-4147-922b-63c95fa6f86b | 2024-12-19 | Warnings | M020 |
| CLE CCC Neutral Light | TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | KW ABSC, INC. | 44cbb226-83ed-401b-baf8-ca8e4740dbef | 2024-12-19 | 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 |