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 | 2026-10-21 | ||
| excluded package | package | 61354-084 | 61354-084-01 | 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 | 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 |
|---|---|---|---|---|---|---|
| Naturium UV Reflect Antioxidant SPF 50 | HOMOSALATE, OCTISALATE, AVOBENZONE | e.l.f. Cosmetics, Inc | 0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c | 2025-11-14 | Warnings | M020 |
| CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | LOreal USA Products Inc | 372894af-bed7-474f-95d4-69a8c3f215ef | 2025-11-14 | Warnings | M020 |
| HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ONEAND CO., LTD. | 2dc41560-f4a7-5f0b-e063-6294a90a0630 | 2025-11-13 | Warnings | M020 |
| Covey Sun and Done Daily Moisturizing | ZINC OXIDE | Covey Skin | fbcf8204-0673-99aa-e053-6294a90ac26e | 2025-11-13 | Warnings | M020 |
| SOL Science The Fifty | ZINC OXIDE | Beauty Pie | 01548858-8b0e-494a-e063-6294a90a8e99 | 2025-11-13 | Warnings | M020 |
| Balmere Mineral Sunscreen Moisturizer Primer | ZINC OXIDE | Balmere | 00d813e0-eb97-a6ba-e063-6394a90aa525 | 2025-11-13 | Warnings | M020 |
| Dove Clinical Care | 96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANT | Conopco d/b/a Unilever | 437eb2a8-428c-8339-e063-6394a90a74b2 | 2025-11-13 | Warnings | M020 |
| Dove Clinical Care | 96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANT | Conopco d/b/a Unilever | 437f4db5-552f-1550-e063-6394a90aaedb | 2025-11-13 | Warnings | M020 |
| Depology Essential Mineral UV Care | ZINC OXIDE | Depology Holdings LLC | 1d48cdee-be67-14c0-e063-6294a90a7422 | 2025-11-13 | Warnings | M020 |
| Hanalei Face Moisturizing | ZINC OXIDE | Hanalei Beauty Company LLC | 1f7c1a68-5aea-0deb-e063-6394a90a3a43 | 2025-11-13 | Warnings | M020 |
| Glo Skin | TITANIUM DIOXIDE, ZINC OXIDE | Glo Skin Beauty | f4bed574-68c1-0d2c-e053-2a95a90a15ff | 2025-11-13 | Warnings | M020 |
| Dove Clinical Care | 96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANT | Conopco d/b/a Unilever | 4380036a-7698-03e7-e063-6294a90a7301 | 2025-11-13 | Warnings | M020 |
| SOME BY MI V10 HYAL AIR FIT SUNSCREEN | SUNSCREENT | PERENNEBELL | fe2148db-9020-9343-e053-6294a90adf70 | 2025-11-13 | Warnings | M020 |
| skin MD | OCTINOXATE, OCTISALATE, HOMOSALATE | 21st Century Formulations | e809e1d3-0a6d-730d-e053-2a95a90aedb9 | 2025-11-13 | Warnings | M020 |
| Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System | TITANIUM DIOXIDE, ZINC OXIDE | Obagi Cosmeceuticals LLC | a64045dd-8f70-43f1-be6f-ad1556c0e210 | 2025-11-13 | Warnings | M020 |
| Florida Glow SPF 50 | AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE | Southeast Holdings Corp. | dcb43ee0-5ab0-495a-8e68-90cab881337d | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 30 | AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE | Southeast Holdings Corp. | 20538bc0-10c3-492c-952a-6797e46003f2 | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 15 | AVOBENZONE,OCTOCRYLENE,OCTISALATE | Southeast Holdings Corp. | 56af704a-bda9-49ed-a177-a8480d90458b | 2025-11-12 | Warnings | M020 |
| Florida Glow face shield SPF 55 | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | Southeast Holdings Corp. | cea54600-5308-4b9f-98ca-fef0b26d79c1 | 2025-11-12 | Warnings | M020 |
| Florida Glow SPF 30 | ZINC OXIDE | Southeast Holdings Corp. | 4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb | 2025-11-12 | 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 |