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 |
|---|---|---|---|---|---|---|
| Sky and Sol Face and Body Sunscreen SPF 50 | NON- NANO ZINC OXIDE | Delta Ecommerce LLC | 473a6ade-1f0a-c711-e063-6294a90a2b83 | 2026-03-30 | Warnings | M020 |
| Vacation by Vacation Scent and Shimmer Duo | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation Inc. | 0c4e6fa1-c78d-4f9d-969f-135d4ed67daf | 2026-03-30 | Warnings | M020 |
| Marie originals - ProActive Sunscreen | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4e3204bf-eda4-2bdf-e063-6394a90ae429 | 2026-03-29 | Warnings | M020 |
| Sport Ultra | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 37c5dcf7-dc2d-624f-e063-6394a90ae992 | 2026-03-29 | Warnings | M020 |
| ULTRALIGHT AGE DEFENSE SPF 50 | ZINC OXIDE | Guangzhou Origin Beauty Cosmetics Co., Ltd. | 4e36a743-7906-2b7b-e063-6294a90af314 | 2026-03-29 | Warnings | M020 |
| Stay Put Sunscreen SPF 30 | OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00% | Sawyer Products Inc | 7ecba495-a912-4697-8287-2e5836e610e1 | 2026-03-27 | Warnings | M020 |
| UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADE | TITANIUM DIOXIDE AND ZINC OXIDE | CLINIQUE LABORATORIES LLC | 4e0bd355-99c6-8cf4-e063-6294a90ab4b3 | 2026-03-27 | Warnings | M020 |
| Vacation X AZ Lemon Tea Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 61c48acc-f589-40d3-b289-b777db5551db | 2026-03-27 | Warnings | M020 |
| Truly Solar Baby Suncreen SPF 45 | HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3% | Truly Beauty, Inc | 38e6c6fc-d8b9-4196-96c7-0f6d5d06da02 | 2026-03-26 | Warnings | M020 |
| burnd | HOMOSALATE, OCTINOXATE, ZINC OXIDE | BURND LLC | 31cf923e-fdde-790b-e063-6294a90a60ee | 2026-03-26 | Warnings | M020 |
| SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On Mineral | ZINC OXIDE, TITANIUM DIOXIDE | Classic Cosmetics LLC | 4df3b8c0-71bc-acdd-e063-6394a90a35c0 | 2026-03-26 | Warnings | M020 |
| COSRX | VITAMIN E VITALIZING SUNSCREEN | COSRX inc. | 4df77564-9da0-7e48-e063-6294a90a5e6b | 2026-03-26 | Warnings | M020 |
| Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30 | AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 3804a14b-be7c-a973-e063-6294a90ac7fc | 2026-03-25 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | c504463a-28bf-4161-875f-ef73520931c5 | 2026-03-25 | Warnings | M020 |
| Mentholatum Natural Ice Cherry, SPF 15 Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 37f2c3a6-7790-c8ec-e063-6294a90ace22 | 2026-03-25 | Warnings | M020 |
| Mentholatum Natural Ice - Original, SPF 15 Original | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 37dc44aa-17b2-8721-e063-6294a90a34f6 | 2026-03-25 | Warnings | M020 |
| ISNTREE HYALURONIC ACID DAILY SUNGEL | AVOBENZONE, HOMOSALATE, OCTISALATE | ISNTREE Inc. | 0ef5d5ce-3bdf-dffc-e063-6394a90aad54 | 2026-03-25 | Warnings | M020 |
| Silkscreen Sheer Tint Mineral Light-Medium | TITANIUM DIOXIDE, ZINC OXIDE | Curology | 4ddbe349-6880-a5fc-e063-6294a90a275c | 2026-03-25 | Warnings | M020 |
| AXIS-Y Complete No-Stress Physical Sunscreen V.3 | ZINC OXIDE | Asia Master Trade Co.,Ltd | 1f310fb1-185a-b467-e063-6294a90a72fe | 2026-03-25 | Warnings | M020 |
| BANANA BOAT | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | 4e0450ca-147a-91d7-e063-6394a90ae73b | 2026-03-25 | Warnings | 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 |