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 | 2026-10-30 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-30 |
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 |
|---|---|---|---|---|---|---|
| Target Up and Up SPF 30 Sport Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | TARGET CORPORATION | 22f59a88-02d7-ebdb-e063-6394a90a957b | 2024-09-25 | Warnings | M020 |
| Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen Stick | ZINC OXIDE | TARGET CORPORATION | 22f7c376-7289-04bf-e063-6394a90a1459 | 2024-09-25 | Warnings | M020 |
| Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen | ZINC OXIDE | TARGET CORPORATION | 22f86630-d4b4-8ad7-e063-6394a90a8d1e | 2024-09-25 | Warnings | M020 |
| Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen | ZINC OXIDE | TARGET CORPORATION | 22f9044a-f54c-b34b-e063-6394a90a88ee | 2024-09-25 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE ,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 22e2b447-bd6b-5e8a-e063-6394a90a0de9 | 2024-09-24 | Warnings | M020 |
| Luminous Defense SPF 50 | ZINC OXIDE | Levels 2 Skin | 22e177b3-beea-212e-e063-6394a90a1452 | 2024-09-24 | Warnings | M020 |
| Target Up and Up SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | TARGET CORPORATION | 22e359cd-4c63-b124-e063-6394a90aec73 | 2024-09-24 | Warnings | M020 |
| Bright as Day Mineral SPF50 | ZINC OXIDE | Koco Life LLC | 1c245a53-4098-62e6-e063-6294a90abf12 | 2024-09-23 | Warnings | M020 |
| Pure Protect Mineral Sunscreen Stick SPF50 | ZINC OXIDE | Koco Life LLC | 22cd5999-9b9a-91a3-e063-6394a90a0da5 | 2024-09-23 | Warnings | M020 |
| ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen | ZINC OXIDE | Absolutely Natural | eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea | 2024-09-23 | Warnings | M020 |
| SUNSCREEN 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 229dabbc-9043-3c9d-e063-6394a90a5692 | 2024-09-21 | Warnings | M020 |
| GLC OG Natural Tinted SPF 30 Sunscreen | ZINC OXIDE | GUD LIFE CO. LLC | 25e1e8ec-e19d-45f7-b339-5d12c2b511d6 | 2024-09-18 | Warnings | M020 |
| Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum | AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE | TARGET CORPORATION | bad7d56e-662e-0776-e053-2a95a90a0af0 | 2024-09-18 | Warnings | M020 |
| Target Up and Up Kids SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | TARGET CORPORATION | b82b6d0d-616d-f041-e053-2995a90ae6a3 | 2024-09-18 | Warnings | M020 |
| Note BB Advanced Skin Corrector SPF 15, 01 | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | ef4ec3ae-809a-4608-96ca-4d8ad96380d8 | 2024-09-16 | Warnings | M020 |
| Note BB Advanced Skin Corrector SPF 15, 02 | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | 1e0ea43a-0c43-4994-a927-56ea6d721ccc | 2024-09-16 | Warnings | M020 |
| Note BB 200 Soft Ivory | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | 0a53f010-5cb4-43e3-88e8-0d9641bd131f | 2024-09-16 | Warnings | M020 |
| Note BB 300 Light Beige | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | 92c7212a-1f85-4076-99c8-4db2a77ef69d | 2024-09-16 | Warnings | M020 |
| Note BB 500 | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | 0a02afa5-da58-4813-aab3-6d541e4fec20 | 2024-09-16 | Warnings | M020 |
| Note Mattifying Extreme Wear Foundation 03 Medium Beige | OCTINOXATE | ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI | feac1cc2-eb4c-43da-89fc-6c950202b00d | 2024-09-16 | 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 |