Powder
- Product NDC
- 61354-118
- 11-digit product format
- 613540118
- Labeler code
- 61354
- Product ID
- 61354-118_348c5e36-13f6-cc86-e063-6394a90a8de8
- 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 |
|---|---|
| 08b7eeeb-09ae-ffe6-e063-6294a90aba90 | 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 |
|---|---|---|---|---|---|---|
| 61354-118-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 2 | |
| 61354-118-02 | Powder | 1 in 1 CARTON | POWDER | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| Land Shark SPF 40 | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d204c38c-b5d1-3511-e053-2a95a90a9dc8 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e4e63c-3e51-0a78-e053-2a95a90abd87 | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 8cd68b09-2578-4519-b00e-e83e0e440815 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e44be7-3a46-34e2-e053-2a95a90a9660 | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 005a9e7c-e392-4b9a-911f-d7586f7ae94e | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559d349-2ffd-492c-e053-2995a90aab06 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pink Beach | ZINC OXIDE | Tropical Seas, Inc. | d240e6c9-d053-9924-e053-2a95a90a855a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e49c6f-477b-aafc-e053-2a95a90a982a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559e03b-f5d3-bd72-e053-2995a90a31ca | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Clear Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d128269b-73fa-e5f3-e053-2995a90af1ed | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 Sport | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e40a7c-b49d-cfc3-e053-2995a90ac27e | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | d5ed3488-aa32-4a63-9996-12c6532c3a4d | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559499c-6109-bf5e-e053-2995a90a4ac7 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e24ca1-d041-355d-e053-2995a90a3d61 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5570cbd-89f5-65d5-e053-2995a90a54d1 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Azure Blue | ZINC OXIDE | Tropical Seas, Inc. | d23fe61a-3ffb-59d0-e053-2995a90a59e6 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b55a0bd0-2a32-2977-e053-2a95a90aa142 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | 06d43525-86d8-f2d9-e063-6394a90afc81 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pacific Purple | ZINC OXIDE | Tropical Seas, Inc. | d240fe7c-9d16-78c9-e053-2a95a90a763c | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 06c1ac52-474c-db5c-e063-6294a90afb5f | 2025-11-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-118-01 | 61354011801 | 100 mg in 1 CUP | 100 mg | Historical | |||
| 61354-118-02 | 61354011802 | 1 CUP in 1 CARTON (61354-118-02) / 100 mg in 1 CUP (61354-118-01) | 1 cup | 2023-10-27 | No | No | Current |