Powder
- Product NDC
- 61354-117
- 11-digit product format
- 613540117
- Labeler code
- 61354
- Product ID
- 61354-117_3e1409fc-06d1-b3a9-e063-6294a90a06e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-27
- Substance
- FERRIC OXIDE RED; TITANIUM DIOXIDE
- Active strength
- 1.75; 10 mg/100mg; mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Powder
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FERRIC OXIDE RED | 1.75 mg/100mg |
| TITANIUM DIOXIDE | 10 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1K09F3G675 | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08b52f29-c1a0-c673-e063-6294a90a9a7a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-117-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 3 | |
| 61354-117-02 | Powder | 1 in 1 CARTON | POWDER | 1 | 3 |
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 |
|---|---|---|---|---|---|---|
| Mineral Sunscreen | ZINC OXIDE | ISIS GONZALEZ | 3f68b2ea-be23-100d-e063-6294a90a8b37 | 2025-12-16 | Warnings | M020 |
| Mineral Sunscreen | ZINC OXIDE | ISIS GONZALEZ | 3f682b78-e1c9-e174-e063-6294a90a17ed | 2025-12-16 | Warnings | M020 |
| Silk Screen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Skin Science Institute Inc | 36c3793a-ccb5-1e5f-e063-6294a90ad44f | 2025-12-16 | M020 | |
| Silk Screen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Skin Science Institute Inc | 36c3a721-6be1-3f7f-e063-6394a90a522f | 2025-12-16 | M020 | |
| True Tone Tinted | TITANIUM DIOXIDE, ZINC OXIDE | That Face PLLC | 36c2bb0e-479d-89cd-e063-6294a90aa3d4 | 2025-12-16 | M020 | |
| True Tone Non Tinted | ZINC OXIDE | That Face PLLC | 36c2f263-67cf-e8cf-e063-6394a90ad81f | 2025-12-16 | M020 | |
| Tinted Daily Protection Sunscreen | ZINC OXIDE | Kemmi Lee Skin Science | 37ef5a05-54d2-a8e4-e063-6394a90a8e48 | 2025-12-16 | M020 | |
| Aquaphor Lip Repair Stick and Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | d469bddf-90d4-7b1c-e053-2a95a90a1ed9 | 2025-12-16 | Warnings | M020 |
| Eucerin Daily Protection Face | ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | Beiersdorf Inc | 76403f03-aee9-4c0b-b331-f79b6953118c | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0400b-8ad9-654b-e063-6294a90ad040 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c00301-ee41-333c-e063-6294a90a61d5 | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c078fa-05f9-ad80-e063-6394a90af3bb | 2025-12-16 | M020 | |
| 20Percent Zinc Oxide Non Tinted | ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c108f6-a928-0a54-e063-6394a90ae686 | 2025-12-16 | M020 | |
| 20Percent Zinc Oxide Non Tinted | ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0ccca-c993-181e-e063-6294a90a7ae6 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0a55d-16d3-086a-e063-6394a90a30cf | 2025-12-16 | M020 | |
| Eucerin Radiant Tone | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 2611e0cb-d56d-6ea1-e063-6294a90a745b | 2025-12-16 | Warnings | M020 |
| Really Great Lip Shield | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c1341d-fbf5-56a5-e063-6294a90aa045 | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen | ZINC OXIDE | KLOE SALON LLC | 36c23c07-2011-3ddb-e063-6294a90a76e9 | 2025-12-16 | M020 | |
| Tinted Mineral Sun Defense | TITANIUM DIOXIDE, ZINC OXIDE | Helen's Haven | 36c465ea-979b-9474-e063-6394a90ab3f8 | 2025-12-16 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Helen's Haven | 36c4a27b-96e9-4f30-e063-6294a90a5655 | 2025-12-16 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-117-01 | 61354011701 | 100 mg in 1 CUP | 100 mg | Historical | |||
| 61354-117-02 | 61354011702 | 1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01) | 1 cup | 2023-10-27 | No | No | Current |