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 |
|---|---|---|---|---|---|---|
| Mineral Lip Balm SPF-15 | ZINC OXIDE | TUBBY TODD | 4d938672-5302-4e47-a582-c3e6467008cb | 2024-12-18 | Warnings | M020 |
| SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30 | ZINC OXIDE | Saltyface Natural Inc | f0cc7ce9-81b3-439f-b5ee-96138de54e78 | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | e999d752-6c00-459e-b6c3-d264c330597d | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | f22626c1-0996-41d8-a2ec-3bf7491df657 | 2024-12-18 | Warnings | M020 |
| Costa Sea Mineral Sunscreen SPF 50 | ZINC OXIDE | COSTA SEA INC | 841e1b3d-dbbc-4bb0-886a-fb2d077ae739 | 2024-12-18 | Warnings | M020 |
| SPF 50 plus Sunscreen All Mineral Active Ingredients | TITANIUM DIOXIDE AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 247aae3d-1845-4dd8-b774-b9e8214809a2 | 2024-12-18 | Warnings | M020 |
| Softlips Vanilla, Watermelon, Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 2235d029-157e-4a30-be90-605e6bc143fd | 2024-12-17 | Warnings | M020 |
| Softlips Salted Caramel, Candy Apple, Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 42cf4623-0eb8-455a-b374-8e17e9336b92 | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 0338c078-695d-4d4e-9e90-5a8a98d49524 | 2024-12-17 | Warnings | M020 |
| Softlips Pearl Plus Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 107bcaa9-4347-4979-be44-35183a9ee67e | 2024-12-17 | Warnings | M020 |
| Softlips Raspberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | d18b4c19-0365-44ec-bea8-4328e537e0d8 | 2024-12-17 | Warnings | M020 |
| Softlips Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 03062f13-270d-49cf-8939-2349f12e9cba | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | f733747a-ad1a-4222-baf1-69dcd90a3350 | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 | 2024-12-17 | Warnings | M020 |
| Softlips Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a | 2024-12-17 | Warnings | M020 |
| Softlips Pearl | OCTINOXATE, OCTISALATE | The Mentholatum Company | 43e175b4-7a48-431e-bf27-9ce7dee53f5e | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Watermelon Blackberry | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | e1213808-4dad-4fd0-871a-04bba094a3cc | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | 7c8a4921-ae45-47fb-a64e-c72b1a386d0d | 2024-12-17 | Warnings | M020 |
| Mentholatum Medicated Lip Balm Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 6edb132d-bb67-4e6c-8e18-db0305073a71 | 2024-12-17 | 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 |