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 |
|---|---|---|---|---|---|---|
| Perfecting BB Beauty Balm Natural Tint SPF 30 | ZINC OXIDE | Andalou naturals | 16ca3790-9973-4a04-a43c-e0f7b384f147 | 2025-06-11 | Warnings | M020 |
| SOME BY MI V10 HYAL LIP SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE | PERENNEBELL Co., Ltd. | 3690af2b-fe22-3a9a-e063-6294a90a709d | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP | Pacifica Beauty, LLC | 373901f7-0e32-0f32-e063-6394a90abe25 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN | Pacifica Beauty, LLC | 37397b96-ef14-9098-e063-6294a90aafc9 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT | Pacifica Beauty, LLC | 373aba7c-2ae1-8726-e063-6294a90ae3d8 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM | Pacifica Beauty, LLC | 373c29b9-2f75-9777-e063-6394a90a68a6 | 2025-06-10 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374395ea-ab91-de70-e063-6394a90aec56 | 2025-06-10 | Warnings | M020 |
| ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 | ZINC OXIDE | Andalou naturals | aa689e82-6512-46d8-aec9-269f9348d3f8 | 2025-06-09 | Warnings | M020 |
| ALLIES OF SKIN The One SPF-50 Invisible Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | ALLIES GROUP PTE. LTD. | 36e1c61c-33ab-4a5d-853d-119c29632b08 | 2025-06-09 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTION S | TITANIUM DIOXIDE AND ZINC OXIDE | Shiseido Americas Corporation | b2fae1ba-67fe-48ef-b31f-62db34349961 | 2025-06-09 | Warnings | M020 |
| Olay Super Cream with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 372819f1-0813-2cd5-e063-6294a90ac5bf | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Clear | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3806e2f2-ffd1-6d69-e063-6394a90acb44 | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Getaway | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3808613f-88d6-6c1a-e063-6294a90a5bb2 | 2025-06-09 | Warnings | M020 |
| 1000 Roses Daily Shade Facial SPF 18 | OCTISALATE, OCTOCRYLENE, AND AVOBENZONE | Andalou naturals | 0923e090-6834-4373-80fe-21f00b8c1c17 | 2025-06-09 | Warnings | M020 |
| dAlba Vegan Fresh Sun Cushion | ZINC OXIDE, HOMOSALATE, OCTOCRYLENE | ADMTMAX LLC | 20afcbab-a2f4-7965-e063-6294a90a83d1 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Mild Sunscreen | ZINC OXIDE | ADMTMAX LLC | 20ab5698-cd9f-0821-e063-6394a90a60d7 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Fresh Sun Stick | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE | ADMTMAX LLC | 20ae82ae-bc8f-89d1-e063-6394a90afff2 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Essence Sunscreen | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE | ADMTMAX LLC | 1ccfa213-2f83-ad50-e063-6294a90a38bf | 2025-06-08 | Warnings | M020 |
| Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium | ZINC OXIDE | Pacifica Beauty, LLC | 36ec6c9d-f7dc-0419-e063-6294a90a55e6 | 2025-06-06 | Warnings | M020 |
| Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair | ZINC OXIDE | Pacifica Beauty, LLC | 36ed9101-249a-922c-e063-6394a90a2608 | 2025-06-06 | 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 |