Cream
- Product NDC
- 61354-088
- Requested package NDC
- 61354-088-01
- 11-digit product format
- 613540088
- Labeler code
- 61354
- Product ID
- 61354-088_e77748ac-2f7b-5fb9-e053-2a95a90a0eaf
- 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 package | package | 61354-088 | 61354-088-01 | I | Inactivated by FDA | 2026-10-21 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 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 |
|---|---|---|---|---|---|
| 61354-088-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-7b70-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 |
|---|---|---|---|---|---|---|
| 61354-088-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | 1 | |
| 61354-088-01 | 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 |
|---|---|---|---|---|---|---|
| Poolside Golden Hour SPF 15 Sunscreen Lip | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 7d0f8319-f0fa-4ea7-bb66-427c5a78145a | 2026-02-10 | Warnings | M020 |
| Tanri Broad Spectrum SPF 30 | SUNSCREEN | I. Shay Cosmetics | 26d5b9d1-d669-3430-e063-6394a90ad7f2 | 2026-02-10 | Warnings | M020 |
| DAILY SUNSCREEN BROAD SPECTRUM SPF 30 | ZINC OXIDE | S+ | 9d6ffe56-debc-4ad2-837b-fd7bb091a56f | 2026-02-09 | Warnings | M020 |
| Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | a9c970c8-b6e3-b0a1-e053-2a95a90a89c7 | 2026-02-09 | Warnings | M020 |
| Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face | ZINC OXIDE | Solavida, LLC | 4a694cdf-496b-3bc0-e063-6294a90af0d1 | 2026-02-09 | Warnings | M020 |
| numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BENOW BEAUTY INC | 32bfb17c-5535-c016-e063-6394a90a1814 | 2026-02-09 | Warnings | M020 |
| TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Trader Joe's Company | 4a6b69ed-2739-d22a-e063-6294a90a1e52 | 2026-02-09 | Warnings | M020 |
| SUNPLUS LIP LIFE | SUNSCREEN | I. Shay Cosmetics | 26d28286-e812-0fb3-e063-6394a90a338d | 2026-02-09 | Warnings | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | bb86322d-ff30-4a54-97b5-1be275067146 | 2026-02-06 | Warnings | M020 |
| Hampton Sun SPF 50 Mineral | ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00% | S&C Hampton Sun LLC | d6c33436-042e-44e8-8b55-98be6e246879 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO COLOR-SMART DAY MOISTURIZER | OCTINOXATE, TITANIUM DIOXIDE | Shiseido Americas Corporation | f291f077-1c72-48fc-bb19-c20bdeaaa596 | 2026-02-06 | Warnings | M020 |
| SHISEIDO WASO SHIKULIME COLOR CONTROL | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Shiseido Americas Corporation | f225a736-2ff7-4084-88a4-a8df5b043cce | 2026-02-06 | Warnings | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | American Sales Company | 79dff6ec-d958-4bba-999b-da4aa67519f5 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate, Octocrylene | SUNSCREEN | Retail Business Services, LLC | 1dc325bb-d520-4897-b8f8-3f0ecba2274c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | d8a55217-ae50-4c7f-a440-f4de079d08ae | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | f2a4b432-118e-42a4-baeb-90614dccbd06 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 232ab407-1903-45d8-a2b2-6992ffd30d00 | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 0ccef180-0eb1-cf2b-e063-6394a90adf0c | 2026-02-06 | Warnings, Adverse reactions | M020 |
| Sunscreen for Kids SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 6a455f1a-4285-44c3-820a-85a50d1bbc5b | 2026-02-06 | Warnings | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Retail Business Services, LLC | 15bf22f5-a8f5-44bb-b787-2b762b330d61 | 2026-02-06 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-088-01 | 61354008801 | 1 TUBE in 1 CARTON (61354-088-01) > 100 mg in 1 TUBE | 1 tube | 2022-08-30 | 0000-00-00 | No | No | Current |