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 | 2026-10-16 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Coppertone Every Tone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | f3e3f4c6-2cb9-7b17-e053-2a95a90a3854 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Age Defense Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23f88c88-b68e-4706-e063-6294a90afb38 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d473113d-2fc3-6b1c-e053-2a95a90a88ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% | Beiersdorf Inc | d89df7a5-7741-3e1d-e053-2995a90ae275 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d475e14f-dab1-dec5-e053-2995a90aef73 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d4757d99-bac6-48fb-e053-2a95a90ab1bf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 24d3fbbc-0bce-b47a-e063-6394a90a9afa | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Light | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Fair | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6892952a-d032-30bf-e053-2a91aa0a3bba | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Medium Tan | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Medium | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 68a4ed34-f492-67a6-e053-2a91aa0a0428 | 2025-12-31 | Warnings | M020 |
| Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen | SUNSCREEN | Melaleuca Inc. | 1f1d1575-cf37-5d66-e063-6394a90ab2a3 | 2025-12-31 | Warnings | M020 |
| Eucerin Daily Hydration | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | c9bb7d33-783b-4cbb-a130-91f92d4cc137 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | a13e5326-73c3-9fa8-e053-2a95a90aae9d | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | a13e3f45-8e6f-6a3f-e053-2995a90a17d2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Deep 550 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e31a82-0cd0-5a1a-e053-2991aa0a33f8 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2dfaa-d173-e6a9-e053-2a91aa0a4663 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 300 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e2e541-c583-0f12-e053-2991aa0a4ab2 | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30231-4fba-35d4-e053-2991aa0a33cb | 2025-12-31 | Warnings | M020 |
| Sei Bella Tinted BB Moisturizing Creme Medium 440 N | TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% | Melaleuca Inc. | 68e30255-5640-3b4a-e053-2991aa0ab3f7 | 2025-12-31 | 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 |