Powder
- Product NDC
- 61354-189
- Requested package NDC
- 61354-189-01
- 11-digit product format
- 613540189
- Labeler code
- 61354
- Product ID
- 61354-189_4d39fb2d-8fa3-07c9-e063-6394a90a0d4e
- 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
- 2025-07-25
- Substance
- TITANIUM DIOXIDE
- Active strength
- 10 mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 10 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d39ed7a-ca80-893c-e063-6294a90a03e7 | 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 |
|---|---|---|---|---|---|---|
| 61354-189-01 | Powder | 1 in 1 CARTON | POWDER | 1 | 1 | |
| 61354-189-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 1 |
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 |
|---|---|---|---|---|---|---|
| YOUR SKIN BUT BETTER CC ILLUMINATION FAIR | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | 4e5764f3-9d9e-460b-ab1e-36f280281dec | 2025-12-19 | Warnings | M020 |
| YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | e700dc6e-e7ae-47ee-9974-430bfd045b4f | 2025-12-19 | Warnings | M020 |
| YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN | TITANIUM DIOXIDE AND ZINC OXIDE | IT COSMETICS, LLC | c7924d60-03fb-4a4d-b718-e324f6f1f65f | 2025-12-19 | Warnings | M020 |
| THE GOLDEN GUARD Browning Radiance Gel Suncare for Body | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 4654c417-faa3-23c6-e063-6394a90a2b5a | 2025-12-19 | Warnings | M020 |
| THE MINERAL MELT Invisible Mineral Suncare for Face | TITANIUM DIOXIDE, ZINC OXIDE | Dune Suncare, Inc. | 46557319-7546-e712-e063-6394a90a3cfe | 2025-12-19 | Warnings | M020 |
| Sand Cloud Mineral Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Sand Cloud Holdings, LLC | ff477199-9b01-fc90-e053-6294a90a5102 | 2025-12-19 | Warnings | M020 |
| Sand Cloud Mineral Sunscreen For Face | TITANIUM DIOXIDE AND ZINC OXIDE | Sand Cloud Holdings, LLC | ff2346c6-d911-87b3-e053-6394a90ac6f8 | 2025-12-19 | Warnings | M020 |
| Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Shell | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields | 12c63195-8707-4df0-a4d3-6f31c543db7a | 2025-12-19 | Warnings | M020 |
| EltaMD UV SPF35 | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 3029d6ed-a60b-4789-a567-d09b12d76bf4 | 2025-12-19 | Warnings | M020 |
| OUHOE Universal Colored Moisturizer | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4634fdcd-6f0e-25ca-e063-6294a90a196e | 2025-12-18 | Warnings | M020 |
| SUNSCREEN SPRAY150mL | ZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5% | Foshan Sugar Max Cosmetics CO.,Ltd | 4635f90a-bbc9-0676-e063-6394a90a9f35 | 2025-12-18 | Warnings | M020 |
| Sunscreen Stick | HOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 4637503c-46dc-68de-e063-6394a90abdc7 | 2025-12-18 | Warnings | M020 |
| HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e78c9ae0-c2ef-12ce-e053-2995a90abf1c | 2025-12-18 | Warnings | M020 |
| NARS PURE RADIANT TINTED MOISTURIZER Cuzco | OCTINOXATE, TITANIUM DIOXIDE | NARS Cosmetics | 5bb5d035-16d9-4843-b9aa-d30730c88508 | 2025-12-18 | Warnings | M020 |
| Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 248be719-edff-f40d-e063-6394a90a4ef6 | 2025-12-18 | Warnings | M020 |
| Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 59187729-c166-58fe-e053-2991aa0abe47 | 2025-12-18 | Warnings | M020 |
| GM Collin SPF 25 UVA - UVB Urban Protection Veil Sunscreen | ZINC OXIDE AND TITANIUM DIOXIDE | Laboratoires Dermo-Cosmetik Inc. | 4f0d44ca-09f0-4feb-b78c-77d83e75d4e2 | 2025-12-18 | Warnings | M020 |
| Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | The Procter & Gamble Manufacturing Company | 60a304b1-eee5-408b-e053-2a91aa0a0a08 | 2025-12-18 | Warnings | M020 |
| THE BOD GUARD Invisible Gel Sunscreen for Body | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 463fa1ef-d40d-d818-e063-6294a90a5e61 | 2025-12-18 | Warnings | M020 |
| HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | e686a22f-bddc-5d7c-e053-2995a90a7b28 | 2025-12-18 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-189-01 | 61354018901 | 1 CUP in 1 CARTON (61354-189-01) / 100 mg in 1 CUP | 1 cup | 2025-07-25 | No | No | Current |