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 |
|---|---|---|---|---|---|---|
| AHAVA Protecting Body Broad Spectrum SPF 30 | AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | e188c328-3617-4f02-8bc9-47976acf3711 | 2024-12-17 | Warnings | M020 |
| Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc | a1cab79d-0151-49ee-86dc-c2739842e62e | 2024-12-17 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b | 2024-12-17 | Warnings | M020 |
| Even Up Sunscreen SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f9d375af-3c8b-4462-b729-fdd4be929284 | 2024-12-17 | Warnings | M020 |
| ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 | ZINC OXIDE | 9055-7588 Quebec Inc. DBA Attitude | 0d842103-7157-793a-e063-6394a90a6feb | 2024-12-16 | Warnings | M020 |
| SPF15 natural lip balm 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 295f2a15-19fa-011f-e063-6394a90aea7b | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | Bobbi Brown Professional Cosmetics Inc. | 4bfbfac7-6738-4996-a152-95dfbd759154 | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 | OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | dc6b28ca-b922-460a-8028-fb3f5afdbe9d | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 | OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | 1f9a4b71-45aa-4156-9fe6-ffa81f808a85 | 2024-12-16 | Warnings | M020 |
| AHAVA Protecting Moisturizing SPF50 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 7502e06d-754b-4cb8-ba4c-91eee0453932 | 2024-12-16 | Warnings | M020 |
| Natural Finish Pressed Foundation SPF 20 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c389e183-bfad-4813-af09-fae3aa05e82a | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Brush-On Shield SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c77357f1-7ada-4325-86f7-5ee801610f42 | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 | ZINC OXIDE | Colorescience | 5b6f906e-6620-48b0-9c39-0eb1c8dc1c63 | 2024-12-16 | Warnings | M020 |
| Ryshi SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Rite Aid | e313350f-74d9-370b-e053-2995a90aeeaf | 2024-12-15 | Warnings | M020 |
| Annmarie SPF 20 Sunscreen | ZINC OXIDE 15% | Annmarie Gianni Skin Care LLC | cc722ce1-0ded-19d5-e053-2995a90a7d03 | 2024-12-15 | Warnings | M020 |
| Zinka SPF 30 Clear Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Zinka, Inc | c054ac39-d03f-17c1-e053-2a95a90aa5ef | 2024-12-15 | Warnings | M020 |
| QC SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | CDMA | f82080b1-ef90-a027-e053-6294a90a19f2 | 2024-12-15 | Warnings | M020 |
| QC SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | CDMA | f80ceb05-0bd4-1355-e053-6294a90afb19 | 2024-12-15 | Warnings | M020 |
| Lip Shine SPF35 Sunscreen | ZINC OXIDE | Colorescience | 3a6506c4-1ba9-493a-a4c8-e5f9c60d221b | 2024-12-13 | Warnings | M020 |
| MILK TINT SPF 43 TINTED PRIMER SERUM DEEP | ZINC OXIDE | COSMAX USA, CORPORATION | 292165af-545d-db43-e063-6394a90ad183 | 2024-12-13 | 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 |