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 |
|---|---|---|---|---|---|---|
| AL0043600 Alba Botanica VE Herbal Healing Body | COLLOIDAL OATMEAL | The Hain Celestial Group, Inc. | 60672feb-141f-651e-e053-2a91aa0af41d | 2025-12-10 | Warnings | M020 |
| UV Defense me. Matte Airy-Fit Sunscreen | ZINC OXIDE | MAGNIF CO., LTD | 459f2b8d-453c-4dee-e063-6394a90a4509 | 2025-12-10 | Warnings | M020 |
| RoC Hydration Plus SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | 45a3e250-8195-344d-e063-6294a90ae681 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | bf3c1474-e353-63a5-e053-2a95a90a9b26 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | f161d754-0c32-2fbe-e053-2a95a90a6b47 | 2025-12-10 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242ff053-b8c0-4f90-e063-6294a90a7bb3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ef1f8-ad12-4f80-e063-6394a90a3e3c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e810d366-0c32-5b1c-e053-2a95a90a622e | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242b7d0e-82d8-793c-e063-6294a90a4aa3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | eb744367-f318-e1e2-e053-2a95a90a2cc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242faaed-e85a-a1d7-e063-6294a90aea92 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247d6c0e-8f88-faf0-e063-6394a90a10da | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1e9a5c77-7027-3b52-e063-6394a90ac0eb | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e8241828-17b2-96c5-e053-2a95a90a12e5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 1176181b-1331-ba68-e063-6394a90a961a | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247b56ad-4b61-8b6f-e063-6394a90af3b6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247afcae-855e-3f69-e063-6394a90a4231 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 24306304-4d0d-c5f0-e063-6394a90afad5 | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1f9c7718-6fde-236c-e063-6394a90afa19 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3482855b-de85-a5a7-e063-6294a90a55ae | 2025-12-09 | 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 |