Cream
- Product NDC
- 78518-005
- 11-digit product format
- 785180005
- Labeler code
- 78518
- Product ID
- 78518-005_e922cd1a-0274-2467-e053-2995a90a0408
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MONAT GLOBAL CORP
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-09-12
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 19 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 | 78518-005 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 78518-005 | 78518-005-01 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 78518-005-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 78518-005-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 78518-005-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 78518-005-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 78518-005-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 78518-005-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 78518-005-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 78518-005-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 78518-005-01 | 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 |
|---|---|---|---|---|---|
| 78518-005-01 | 2024-01-11 | C162847 | 48780-1 | 0191ceaa-6cd3-198a-e063-dbdaa90aec3e | BB Cream SPF 40 Broad-Spectrum Moisturizer (Cedar) |
| 78518-005-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6cd3-198a-e063-dbdaa90aec3e | BB Cream SPF 40 Broad-Spectrum Moisturizer (Cedar) |
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 |
|---|---|---|---|---|---|---|
| Safe Sea SPF sport 65 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 0ed3242b-ac35-4d98-a777-1e44bb32a467 | 2025-12-08 | Warnings | M020 |
| Safe Sea SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 46641a33-d658-4ef0-9b7a-062adc401dde | 2025-12-08 | Warnings | M020 |
| Skin Filter Glow SPF | ZINC OXIDE | MALORIE MILES | 36485f44-a6bd-9529-e063-6294a90af7a4 | 2025-12-08 | M020 | |
| Skin Filter Matte SPF | TITANIUM DIOXIDE, ZINC OXIDE | MALORIE MILES | 3647f983-9e75-8955-e063-6294a90af162 | 2025-12-08 | M020 | |
| Body-Screen | ZINC OXIDE | MALORIE MILES | 36499be5-d680-92bf-e063-6394a90a89db | 2025-12-08 | M020 | |
| Skin Filter Matte SPF | TITANIUM DIOXIDE, ZINC OXIDE | MALORIE MILES | 3649f758-e31b-3c6a-e063-6294a90a5c36 | 2025-12-08 | M020 | |
| Body-Screen | ZINC OXIDE | MALORIE MILES | 364ae392-480a-14ea-e063-6394a90a3883 | 2025-12-08 | M020 | |
| Personalized Moisturizer SPF 30 | ZINC OXIDE 10.00% | Proven Skincare | d3cf8f81-d6ae-4570-ad86-43415e973e13 | 2025-12-08 | Warnings | M020 |
| GLOW SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2f9d087c-b2b3-5654-e063-6294a90a94e5 | 2025-12-08 | Warnings | M020 |
| MATTE SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2faee7ef-fc0c-6d01-e063-6294a90a6d68 | 2025-12-08 | Warnings | M020 |
| GLOW SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2faf530d-5574-b702-e063-6294a90ad6fd | 2025-12-08 | Warnings | M020 |
| MATTE SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2fb00db0-4c37-56c6-e063-6294a90a8aff | 2025-12-08 | Warnings | M020 |
| Matte Shield SPF | TITANIUM DIOXIDE, ZINC OXIDE | ACNE SOLUTIONS NYC INC | 3bb582ec-71e7-4ad8-e063-6394a90a94d4 | 2025-12-08 | Warnings | M020 |
| SPF 101 Lightly Tinted | ZINC OXIDE | The Acne Lab LLC | 334afdc8-1e12-d787-e063-6294a90aed7c | 2025-12-08 | M020 | |
| SPF 101 Non-Tinted | ZINC OXIDE | The Acne Lab LLC | 334bf8ea-2485-84e8-e063-6294a90aefa6 | 2025-12-08 | M020 | |
| SPF 101 Lightly Tinted | ZINC OXIDE | The Acne Lab LLC | 334d694a-f9e4-ae86-e063-6394a90abfe1 | 2025-12-08 | M020 | |
| SPF 101 Non-Tinted | ZINC OXIDE | The Acne Lab LLC | 334e32a4-c3a5-e37d-e063-6294a90ad6cf | 2025-12-08 | M020 | |
| Mineral Based Sunscreen Stick Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3245561d-a90c-7bf0-e063-6394a90ab3b6 | 2025-12-08 | M020 | |
| Mineral Based Sunscreen Stick Tinted | TITANIUM DIOXIDE, ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3245c1f7-2c1b-b6ad-e063-6394a90aaee6 | 2025-12-08 | M020 | |
| Mineral Based Facial Sunscreen | ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3e8981ed-5847-7009-e063-6394a90a49a1 | 2025-12-08 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78518-005-01 | 78518000501 | 1 TUBE in 1 CARTON (78518-005-01) > 35 mg in 1 TUBE | 1 tube | 2022-09-12 | 0000-00-00 | No | No | Current |