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 |
|---|---|---|---|---|---|---|
| Matte Velvet Tint | TITANIUM DIOXIDE, ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 359641c5-0e19-f243-e063-6394a90aeebc | 2025-12-12 | M020 | |
| Satin Tint | ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 359684cf-ca11-f9af-e063-6394a90ac4c1 | 2025-12-12 | M020 | |
| TINTED MINERAL SUNSCREEN SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | DERMATOLOGY ARTS | 35814d5d-fd34-05b3-e063-6294a90aadd1 | 2025-12-12 | M020 | |
| JAYSUING Rice Probiotics Sunscreen | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 45cdc741-9ce0-fd6c-e063-6294a90adc0b | 2025-12-12 | Warnings | M020 |
| Tinted Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA HAIR DESIGN | 36eb4cd3-778c-362f-e063-6294a90a059c | 2025-12-11 | M020 | |
| Matte Finish | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37630c6c-f768-7b3e-e063-6394a90af565 | 2025-12-11 | M020 | |
| Signature Tint SPF 40 | ZINC OXIDE | ADVANCED AESTHETICS SKIN CARE STUDIO, INC | 348f1bd3-1245-2d9a-e063-6394a90a4787 | 2025-12-11 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | ADVANCED AESTHETICS SKIN CARE STUDIO, INC | 348fcc63-d8e3-90a1-e063-6294a90ade11 | 2025-12-11 | M020 | |
| Tinted Sunscreen | ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a54441-c741-0c46-e063-6294a90a9be8 | 2025-12-11 | M020 | |
| Instant Glow | ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37620171-140d-e096-e063-6294a90af93b | 2025-12-11 | M020 | |
| Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique Aesthetics Pllc | 34a49563-c74b-2fd1-e063-6394a90a6c56 | 2025-12-11 | M020 | |
| Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a52011-b781-75cf-e063-6394a90ae0f4 | 2025-12-11 | M020 | |
| Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a632f5-4458-e335-e063-6394a90a9bcb | 2025-12-11 | M020 | |
| D FEND DAILY | ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 3762dc16-055e-43fd-e063-6394a90ad3c8 | 2025-12-11 | M020 | |
| Tinted Sunscreen | ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a66140-0d36-005a-e063-6394a90a2a0b | 2025-12-11 | M020 | |
| Instant Glow | ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37634726-fb70-f209-e063-6294a90a5d3b | 2025-12-11 | M020 | |
| Matte Finish | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 3761d74c-0137-0c75-e063-6394a90a3c7d | 2025-12-11 | M020 | |
| Sun Plus Sun Lip Shield | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 3763a79a-e881-cade-e063-6394a90a49de | 2025-12-11 | M020 | |
| Tinted Minerals 1point8 oz | TITANIUM DIOXIDE, ZINC OXIDE | SPECKTRA6 LLC | 374e53c6-307f-f8e5-e063-6394a90a07ef | 2025-12-11 | M020 | |
| Tinted Minerals 1point8 oz | TITANIUM DIOXIDE, ZINC OXIDE | SPECKTRA6 LLC | 373e29f1-d665-a3c4-e063-6294a90a403e | 2025-12-11 | 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 |