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 | 2026-10-15 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | c76f5639-bd0f-4987-8c70-224ee33bbbad | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 8795b9a7-1938-4dd9-92ad-3c044feae1da | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3f8bad95-8071-47b1-88a7-3a3f09f097b5 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| UV RESTORE FACE SERUM SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | BETTER INNOVATION LTD | 4b9a881a-835b-ef0c-e063-6394a90a94af | 2026-02-24 | Warnings | M020 |
| MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a9303-662f-9614-e063-6294a90a6b51 | 2026-02-24 | Warnings | M020 |
| SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9ac780-ef7d-42fc-e063-6394a90ad62f | 2026-02-24 | Warnings | M020 |
| PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9b36a6-4da9-8439-e063-6394a90aa86b | 2026-02-24 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | M020 |
| cle de peau BEAUTE ADVANCED PROTECTIVE DAY | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 710975d8-43bf-40b9-82c2-d4dc2988956d | 2026-02-23 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | M020 |
| Eryfotona Ageless | ZINC OXIDE | ISDIN Corp. | a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f | 2026-02-23 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | M020 |
| Beauty Hydrating | HOMOSALATE, ZINC OXIDE | Meijer, Inc. | 69b72139-757f-476d-99d2-33f5524c41d2 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| daily moisturizer | AVBENZONE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 6d301146-46e0-445c-b14e-3ec8ce76cb45 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | e9f4a2bb-d21e-4b38-9a37-23c23c8ad857 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Ink-eeze | 3f759bec-4e33-46fa-a800-fa3a17d63df9 | 2026-02-19 | Warnings | M020 |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | M020 |
| e.l.f. Best and Obsessed Skincare Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 4b1c1150-5ac5-4a8b-e063-6394a90a5410 | 2026-02-18 | Warnings | M020 |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | M020 |
| Degree Clinical | COOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANT | Conopco Inc. d/b/a/ Unilever | 4b1f9fd3-3c49-9a98-e063-6294a90a20e0 | 2026-02-18 | 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 |