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 | 2026-10-23 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15 | AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE | Meaningful Beauty, LLC | f59fe019-569b-49ba-accf-fa4d356ce96b | 2025-05-12 | Warnings | M020 |
| Cicatricure Gold Lift SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Genomma Lab USA | 34cc5b3c-af36-e202-e063-6294a90a13a7 | 2025-05-10 | Warnings | M020 |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | The Maui Medical Group, Inc | 34b6aa46-657b-2676-e063-6294a90abadd | 2025-05-09 | M020 | |
| Tinted Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a5a99f-9e22-52ab-e063-6294a90a9323 | 2025-05-08 | M020 | |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b7eeeb-09ae-ffe6-e063-6294a90aba90 | 2025-05-07 | Warnings | M020 |
| cle de peau BEAUTE UV PROTECTIVE N | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | fe19a057-a3c6-4c53-92f9-a4a960cd5b08 | 2025-05-07 | Warnings | M020 |
| Winter Survival Kit | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | Duke Cannon Supply Co. | 2487ab56-7856-66b0-e063-6394a90a9d87 | 2025-05-07 | Warnings | M020 |
| OS-01 Lip SPF BS SPF15 | ZINC OXIDE | Allure Labs | 3490ed60-60b9-dfcd-e063-6394a90ab17a | 2025-05-07 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Nude Beige | ZINC OXIDE | Koco Life LLC | 3491084b-348a-f2bf-e063-6394a90abd25 | 2025-05-07 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Watermelon | ZINC OXIDE | Koco Life LLC | 3491fb2a-d55f-1736-e063-6294a90a594a | 2025-05-07 | Warnings | M020 |
| Abib Heartleaf mild sunscreen Relief tube | ZINC OXIDE | FOURCOMPANY CO., LTD. | 34965587-c9b7-4066-e063-6394a90ab424 | 2025-05-07 | Warnings | M020 |
| CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Laboratoires Clarins | 157cb8ca-1a36-41fb-be9e-b157b146dc4d | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 50 Sport | AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions | e25e4f76-8311-491b-e053-2a95a90a4fc8 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e260b901-5918-48df-e053-2a95a90a68c3 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e25cf8e4-93cd-f5f6-e053-2995a90a4545 | 2025-05-06 | Warnings | M020 |
| Mango Bay SPF 30 Gallon | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Inspec Solutions LLC. | e260c1bc-8b79-abc7-e053-2a95a90ae4d2 | 2025-05-06 | Warnings | M020 |
| Lip Love Moisture Balm SPF30 - Pink Strawberry | ZINC OXIDE | Koco Life LLC | 347e665f-cb59-ab04-e063-6394a90ad0a6 | 2025-05-06 | Warnings | M020 |
| Saucd Toasted Golden Tanning SPF 15 Caramel | AVOBENZONE, OCTISALATE, HOMOSALATE | SAUCD GENERAL TRADING COMPANY | e10d41cd-e03e-401c-9024-263350b3ec2a | 2025-05-05 | Warnings | M020 |
| Visor Clear Body Mist Hydrating Sunscreen SPF 50 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | VISOR SKINCARE LLC | b2d7639c-cbfb-4127-8ee4-7355e0d021e1 | 2025-05-05 | Warnings | M020 |
| Jacket Ultimate Performance Sunscreen SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BALSHI MD DERMACEUTICALS | d4d82c41-01da-40af-a22c-d4d57af7a2f2 | 2025-05-05 | 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 |