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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Sun Town City SPF 15 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | c7aaa185-8490-60ec-e053-2995a90adc0d | 2024-10-17 | Warnings | M020 |
| Fruit of the Earth Sun Town City Dark Tanning SPF 8 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | c7aa1e58-f7b3-6b7f-e053-2995a90a957c | 2024-10-17 | Warnings | M020 |
| Fruit of the Earth Sun Town City SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | c7bbad46-5c52-9f1d-e053-2995a90ae139 | 2024-10-17 | Warnings | M020 |
| Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | c7bdd7a3-2e88-d881-e053-2a95a90a2ef9 | 2024-10-17 | Warnings | M020 |
| dermalogica dynamic skin recovery spf 50 | SUNSCREEN | Dermalogica, LLC | 051b77ab-6970-48e4-bbfd-c066178ea32e | 2024-10-17 | Warnings | M020 |
| Hyaluronic Moisturizer | OCTINOXATE, OXYBENZONE. AVOBENZONE | Bentley Laboratories LLC | 88bd6dff-ba19-4f8f-9432-28398d24f1ab | 2024-10-16 | Warnings | M020 |
| EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | United Natural Foods, Inc. dba UNFI | f13feba4-25d8-61d0-e053-2995a90aafa8 | 2024-10-16 | Warnings | M020 |
| Equaline Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | United Natural Foods, Inc. dba UNFI | f0dda684-b0ed-629c-e053-2995a90a1287 | 2024-10-16 | Warnings | M020 |
| EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | United Natural Foods, Inc. dba UNFI | e46d20b3-2897-1370-e053-2a95a90a619c | 2024-10-16 | Warnings | M020 |
| MEIJER BROAD SPECTRUM SPF 30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENE | MEIJER DISTRIBUTION. INC. | a71d34d4-a924-6421-e053-2995a90a647e | 2024-10-16 | Warnings | M020 |
| MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | MEIJER DISTRIBUTION, INC. | a71bf24f-b923-b81f-e053-2995a90a0072 | 2024-10-16 | Warnings | M020 |
| MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREEN | OCTINOXATE, OCTISALATE, ZINC OXIDE | MEIJER DISTRIBUTION INC | a9f4fd45-3bbb-14a7-e053-2995a90ab28f | 2024-10-16 | Warnings | M020 |
| WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | e4b7df52-2bc9-1afc-e053-2a95a90a4f87 | 2024-10-16 | Warnings | M020 |
| Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f12bff9a-bd3c-e35d-e053-2995a90abf17 | 2024-10-16 | Warnings | M020 |
| MINERAL SUNSCREEN SPF 50 | ZINC OXIDE, TITANIUM DIOXIDE | WEGMANS FOOD MARKETS INC | bfe24f55-d0e5-254a-e053-2995a90a2fd3 | 2024-10-16 | Warnings | M020 |
| Wegmans Sport Broad Spectrum SPF 70 Clear Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | WEGMANS FOOD MARKETS INC | e7175821-e514-1bea-e053-2995a90a0c0d | 2024-10-16 | Warnings | M020 |
| Wegmans Kids and Sport Broad Spectrum SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f3463f81-9a65-3796-e053-2995a90a4f80 | 2024-10-16 | Warnings | M020 |
| Wegmans Sheer Broad Spectrum SPF 30 Dry Touch Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f33248fa-695a-fbef-e053-2a95a90abe35 | 2024-10-16 | Warnings | M020 |
| Wegmans Sport Sunscreen Stick SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f5671251-e26b-045f-e053-2a95a90adc03 | 2024-10-16 | Warnings | M020 |
| Wegmans Kids Sunscreen Stick SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f57775c3-5e6c-f47a-e053-2a95a90ab012 | 2024-10-16 | 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 |