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 | 2026-10-05 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-05 |
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 |
|---|---|---|---|---|---|---|
| MELAO Hydrating Lightweight Sunscreen | AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 59eeaea1-d726-99f3-e063-6394a90aeea3 | 2026-08-26 | Warnings | M020 |
| Hero Force Shield Superlight Sunscreen SPF 30 | ZINC OXIDE | Church & Dwight Co., Inc. | 140268a9-adb9-4574-ad82-4a2e924dc808 | 2026-08-26 | Warnings | M020 |
| Juyasuyon Sport Ultra Sunscreen Cream | OCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE | Guangdong Aimu Biological Technology Co., Ltd | 598cfe9e-6ebe-ad18-e063-6294a90ace22 | 2026-08-25 | Warnings | M020 |
| NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | e8cdf9f7-d968-42b3-bcb8-02dee7717fd8 | 2026-08-25 | Warnings | M020 |
| JUYASUYON Sport Ultra Sunscreen | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Guangdong Aimu Biological Technology Co., Ltd | 59d97ee0-e416-53e7-e063-6294a90a9153 | 2026-08-25 | Warnings | M020 |
| NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | ed495f18-2f8e-4991-b797-82e9f6fc7acb | 2026-08-25 | Warnings | M020 |
| Q Skin Science | SUNSCREEN | International Cosmeceuticals, Inc | 59e4c3d0-ee4c-2350-e063-6394a90ac9d2 | 2026-08-25 | Warnings | M020 |
| ISNTREE HYALURONIC ACID WATERY SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ISNTREE Inc. | 59e9279a-2427-d6bc-e063-6394a90ae86e | 2026-08-25 | Warnings | M020 |
| Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | NeoStrata Company Inc. | 4739e678-ce51-4863-bb74-2275879e1b47 | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(YELLOW) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c3009b-ae16-52e1-e063-6394a90a69ee | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(PINK) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c68d9b-9aa9-4996-e063-6394a90a48d4 | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(GREEN) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c70c82-f7ff-9a04-e063-6294a90a7b3d | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(BLUE) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c78929-9df7-5212-e063-6394a90a3766 | 2026-08-24 | Warnings | M020 |
| Dr Marvel COLOR CHANGING FOUNDATION SPF30 | ETHYLHEXYL METHOXYCINNAMATE | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 59c8865f-ccee-dd50-e063-6294a90aa185 | 2026-08-24 | Warnings | M020 |
| Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | 74a998e2-8ebf-436c-aac1-b456cd2e072d | 2026-08-24 | Warnings | M020 |
| Homosalate, Octisalate, Zinc oxide | HOMOSALATE, OCTISALATE, ZINC OXIDE | Aldi Inc | 59cbfb14-d9b1-ce93-e063-6394a90ac312 | 2026-08-24 | Warnings, Adverse reactions | M020 |
| SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 59d74e3f-e3fa-a7a9-e063-6294a90a76e5 | 2026-08-24 | Warnings | M020 |
| ISNTREE HYALURONIC ACID WATERY SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ISNTREE Inc. | 59ac747a-f9c7-2c18-e063-6394a90a2306 | 2026-08-23 | Warnings | M020 |
| Sunski Sol Power Daily Face Sunscreen SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Stewart Charley Ventures, LLC | b6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c | 2026-08-21 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 5990fe66-4fa2-06aa-e063-6294a90a5261 | 2026-08-21 | 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 |