Powder
- Product NDC
- 61354-188
- 11-digit product format
- 613540188
- Labeler code
- 61354
- Product ID
- 61354-188_41c09cb9-0e08-3abc-e063-6294a90a7883
- 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
- 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 |
|---|---|
| 41c0c262-21c3-b8e6-e063-6394a90a7c9c | 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 |
|---|---|---|---|---|---|---|
| 61354-188-01 | Powder | 1 in 1 CARTON | POWDER | 1 | 4 | |
| 61354-188-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 4 |
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 |
|---|---|---|---|---|---|---|
| Mineral Lip Balm SPF-15 | ZINC OXIDE | TUBBY TODD | 4d938672-5302-4e47-a582-c3e6467008cb | 2024-12-18 | Warnings | M020 |
| SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30 | ZINC OXIDE | Saltyface Natural Inc | f0cc7ce9-81b3-439f-b5ee-96138de54e78 | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 Jasmine | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | e999d752-6c00-459e-b6c3-d264c330597d | 2024-12-18 | Warnings | M020 |
| Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | EK Clothing LLC dba Belasol | f22626c1-0996-41d8-a2ec-3bf7491df657 | 2024-12-18 | Warnings | M020 |
| Costa Sea Mineral Sunscreen SPF 50 | ZINC OXIDE | COSTA SEA INC | 841e1b3d-dbbc-4bb0-886a-fb2d077ae739 | 2024-12-18 | Warnings | M020 |
| SPF 50 plus Sunscreen All Mineral Active Ingredients | TITANIUM DIOXIDE AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 247aae3d-1845-4dd8-b774-b9e8214809a2 | 2024-12-18 | Warnings | M020 |
| Softlips Vanilla, Watermelon, Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 2235d029-157e-4a30-be90-605e6bc143fd | 2024-12-17 | Warnings | M020 |
| Softlips Salted Caramel, Candy Apple, Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 42cf4623-0eb8-455a-b374-8e17e9336b92 | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 0338c078-695d-4d4e-9e90-5a8a98d49524 | 2024-12-17 | Warnings | M020 |
| Softlips Pearl Plus Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 107bcaa9-4347-4979-be44-35183a9ee67e | 2024-12-17 | Warnings | M020 |
| Softlips Raspberry | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | d18b4c19-0365-44ec-bea8-4328e537e0d8 | 2024-12-17 | Warnings | M020 |
| Softlips Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 03062f13-270d-49cf-8939-2349f12e9cba | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | f733747a-ad1a-4222-baf1-69dcd90a3350 | 2024-12-17 | Warnings | M020 |
| Softlips Vanilla Watermelon | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97 | 2024-12-17 | Warnings | M020 |
| Softlips Marshmallow Ghost | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8d55141d-5d6f-4eec-87dc-d3c808cf7a6a | 2024-12-17 | Warnings | M020 |
| Softlips Pearl | OCTINOXATE, OCTISALATE | The Mentholatum Company | 43e175b4-7a48-431e-bf27-9ce7dee53f5e | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Watermelon Blackberry | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | e1213808-4dad-4fd0-871a-04bba094a3cc | 2024-12-17 | Warnings | M020 |
| Softlips Peppermint | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 | 2024-12-17 | Warnings | M020 |
| Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi | DIMETHICONE, OXYBENZONE, OCTINOXATE | The Mentholatum Company | 7c8a4921-ae45-47fb-a64e-c72b1a386d0d | 2024-12-17 | Warnings | M020 |
| Mentholatum Medicated Lip Balm Cherry | DIMETHICONE, OCTINOXATE, OCTISALATE | The Mentholatum Company | 6edb132d-bb67-4e6c-8e18-db0305073a71 | 2024-12-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-188-01 | 61354018801 | 1 CUP in 1 CARTON (61354-188-01) / 100 mg in 1 CUP | 1 cup | 2023-10-27 | No | No | Current |