Powder
- Product NDC
- 61354-189
- 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 |
|---|---|---|---|---|---|---|
| FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20 | OCTINOXATE AND TITANIUM DIOXIDE | ESTEE LAUDER INC | 53d9d689-4a86-5b9c-e063-6394a90aef18 | 2026-06-09 | Warnings | M020 |
| TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREEN | ZINC OXIDE | Moes Group LLC | 53c09714-6137-7102-e063-6294a90a72a4 | 2026-06-08 | Warnings | M020 |
| TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREEN | ZINC OXIDE | Moes Group LLC | 53c13cc3-208e-ae7d-e063-6294a90a2a03 | 2026-06-08 | Warnings | M020 |
| Innisfree Daily UV Defense Mineral Sunscreen | ZINC OXIDE LOTION | Innisfree Corporation | 0e9cd3e5-cff8-7594-e063-6394a90aad90 | 2026-06-08 | Warnings | M020 |
| Paulas Choice Lipscreen Broad Spectrum SPF 50 | OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE | Cosmetic Solutions LLC | 4c37e10c-3da5-4a48-b2c1-1b99ce9a02c1 | 2026-06-08 | Warnings | M020 |
| Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen | TITANIUM DIOXIDE | ISDIN Corp. | 293a1116-e8a2-495f-83db-20dd82ed13c2 | 2026-06-08 | Warnings | M020 |
| Inflair Elevate SPF15 Moisturizer | ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANE | Guangzhou Yapheon Health Industry Co., Ltd | 53a724e9-229e-eea4-e063-6294a90a7d5e | 2026-06-07 | Warnings | M020 |
| Eryfotona Actinica Tinted | TITANIUM DIOXIDE | ISDIN Corp. | 97357703-0e93-4216-bd1b-a9b202781959 | 2026-06-05 | Warnings | M020 |
| Invisible Fit Sun Cream | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 537cb611-52f4-13a5-e063-6294a90a9f2a | 2026-06-05 | Warnings | M020 |
| Matte Invisible Mineral Sunscreen | ZINC OXIDE | INTEGRATIVE AESTHETICS BOSTON, LLC | 538429b8-4f0e-e825-e063-6294a90a5905 | 2026-06-05 | Warnings | M020 |
| Matte Invisible Mineral Sunscreen Non-Tinted | ZINC OXIDE | INTEGRATIVE AESTHETICS BOSTON, LLC | 5384da3c-4017-a3c1-e063-6294a90ae9a3 | 2026-06-05 | Warnings | M020 |
| MEDULTIMA ADVENTURE SUNSCREEN | HOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | Guangzhou Tata Biotechnology Co., Ltd. | 5368b2b3-fd80-9659-e063-6394a90a0ad3 | 2026-06-04 | Warnings | M020 |
| WEN SixThirteen SPF 20 Dry Oil Intensive Treatment | OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONE | WEN by Chaz Dean | 536e6291-f5ca-37a4-e063-6394a90adfdb | 2026-06-04 | Warnings | M020 |
| Mineral Mattescreen SPF 40 - Untinted | TITANIUM DIOXIDE, ZINC OXIDE | Supergoop, LLC | 08671d39-3be2-d666-e063-6294a90a6207 | 2026-06-04 | Warnings | M020 |
| Mineral Mattescreen SPF 40 - Golden Hour | TITANIUM DIOXIDE, ZINC OXIDE | Supergoop, LLC | c2398820-f003-707f-e053-2a95a90a6929 | 2026-06-04 | Warnings | M020 |
| Glow Gloss Lip Balm SPF 40 Vanilla Soft Serve | HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE | Supergoop! | 26d2897f-46a7-52b2-e063-6394a90aed32 | 2026-06-04 | Warnings | M020 |
| Epionce Daily Shield Tinted SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Episciences, Inc. | 3d1e2921-cba9-4446-e054-00144ff8d46c | 2026-06-04 | Warnings | M020 |
| Abib No White Cast SPF Gift Set | HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE | FOURCOMPANY CO., LTD. | 537420bb-9fd8-0649-e063-6394a90aa8cf | 2026-06-04 | Warnings | M020 |
| Airy sunstick smooting bar | HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE | FOURCOMPANY CO., LTD. | f8203d54-cd3d-314d-e053-6394a90ac10d | 2026-06-04 | Warnings | M020 |
| Play Everyday Sunscreen SPF 50 with Sunflower Extract | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | 0428eebc-4ffb-4981-b738-2c9ecf2a6a2e | 2026-06-04 | 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 |