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 | 2026-10-27 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c61c42-edc9-1ebd-e063-6294a90aee13 | 2024-12-25 | Warnings | M020 |
| Invisible Sunscreen SPF 40 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | COSMAX USA, CORPORATION | 29fe531e-2ade-170f-e063-6394a90a1396 | 2024-12-24 | Warnings | M020 |
| SOLAR MILK SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 29fe4dad-d1fb-e750-e063-6294a90ab307 | 2024-12-24 | Warnings | M020 |
| CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Chantecaille Beaute Inc | d30cc344-846d-416e-ac57-4a29d4ed8263 | 2024-12-24 | Warnings | M020 |
| Almay Age Smart Shade CC Luminous Primer SPF 15 | ZINC OXIDE, TITANIUM DIOXIDE MAKE-UP | Almay, Inc. | 281557c0-e668-4436-86a7-3f583091e4e4 | 2024-12-24 | Warnings | M020 |
| EIGHT HOUR LIP PROTECTANT SPF 15 | PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE | REVLON | 2a0ac6aa-0315-d79e-e063-6294a90a9c53 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Amber | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b311f-9dcc-9b26-e063-6394a90a29a8 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Buff Beige | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b3b8b-d38b-cd4d-e063-6294a90a919a | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Hazel | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b3b8b-d38c-cd4d-e063-6294a90a919a | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Cool Beige | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b48b8-5953-9ab7-e063-6394a90a6b24 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Creamy Natural | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b311f-9dcd-9b26-e063-6394a90a29a8 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Rich Mahogany | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b6b99-883b-ffd4-e063-6294a90a7f4b | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Light Tan | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b557a-ff60-f33f-e063-6394a90ac66f | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Light Beige | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b6b99-8839-ffd4-e063-6294a90a7f4b | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Light Natural | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b668d-036e-893e-e063-6294a90a82af | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Rich Sand | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b6ba3-b5da-f2f7-e063-6394a90a86ae | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Soft Nutmeg | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b856a-d714-892c-e063-6294a90a4ae9 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Sandalwood | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b856a-d712-892c-e063-6294a90a4ae9 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Tan Sand | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b5cca-4e4f-efb6-e063-6294a90a6206 | 2024-12-24 | Warnings | M020 |
| RV Illuminance Serum Tint Broad Spectrum 15 Warm Caramel | FACE FOUNDATION WITH SPF | REVLON CONSUMER PR Consumer Products Corp | 2a0b9147-3c7a-d549-e063-6394a90a6869 | 2024-12-24 | 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 |