Powder
- Product NDC
- 61354-119
- 11-digit product format
- 613540119
- Labeler code
- 61354
- Product ID
- 61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
- 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 |
|---|---|
| 08b8003f-40be-3380-e063-6294a90a4f6b | 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 |
|---|---|---|---|---|---|---|
| 61354-119-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 3 | |
| 61354-119-02 | 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 |
|---|---|---|---|---|---|---|
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bad1502-bc44-54ec-e063-6294a90ace8b | 2026-02-25 | Warnings | M020 |
| Truskin SPF 30 Mineral Sunscreen Facial Serum | ZINC OXIDE | Allure Labs | 2e20c132-8a03-1d5d-e063-6394a90ad2c3 | 2026-02-25 | Warnings | M020 |
| Rationale The Brilliance Tinted Serum SPF 50 | ZINC OXIDE | RATIONALE GROUP PTY LTD | 5c38506b-1533-435f-87a6-0452bae5b29f | 2026-02-24 | Warnings | M020 |
| FULLY RICE CERAMIDE MOISTURE SUNSCREEN | ZINC OXIDE | Adapt Inc. | d8bfe222-3184-4c98-9876-ef5ac81772b6 | 2026-02-24 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N M O20 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 9507f6d1-c11c-428d-8d95-b436f27ba26a | 2026-02-24 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b93538a-3b3e-90f7-e063-6294a90ab898 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b93cd22-1289-29bc-e063-6294a90ab781 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b943d72-dcde-e2e4-e063-6294a90ab7c4 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING NON-TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b946c39-718b-d70e-e063-6394a90a0db8 | 2026-02-24 | Warnings | M020 |
| Reunited Lipgloss SPF 30 - BTCH IS BACK | HOMOSALATE, OCTOCRYLENE, OCTISALATE | Princeville Productions, LLC, DBA Reunited Beauty | 4b961531-fbca-d1cf-e063-6294a90ab9a1 | 2026-02-24 | Warnings | M020 |
| sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 8f5e634c-765b-4ffe-bb12-753d64c90cf9 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | e97bf30a-1465-4912-bd55-1e7dd993132b | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 67efcd94-00af-477b-bd14-d1c7b95d305a | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen Mist SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | f642788c-3643-459a-b736-0c06d0cd32a9 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 95ba2b33-f593-4e95-bd6e-5910d6aa5158 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3b85004a-8832-4eac-bd70-1e607ae7af4b | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 7f0fc23b-2d70-4426-9d64-a6d2b643309f | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 0ae9edd8-bf76-4bb2-ab78-c43c017ba4a5 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avbenzone, Homosalate, Octisalate | AVBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | f8960995-66b6-4197-8976-b318fe01488f | 2026-02-24 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-119-01 | 61354011901 | 100 mg in 1 CUP | 100 mg | Historical | |||
| 61354-119-02 | 61354011902 | 1 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01) | 1 cup | 2023-10-27 | No | No | Current |