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 |
|---|---|---|---|---|---|---|
| Bath and Body Works SPF At The Beach | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c315bdb-dc33-1737-e063-6294a90a31a4 | 2026-03-02 | Warnings | M020 |
| Bath and Body Works SPF Tahiti Isle | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 38d02c8d-cdc8-b8d6-e063-6294a90ad9e4 | 2026-03-02 | Warnings | M020 |
| Sport | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATE | Old East Main Co. | a460e512-f268-4941-beb6-29df10fdbb3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Tanning Sunscreen SPF 15 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42258ebe-e3cc-4d70-e063-6294a90a9651 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE | Old East Main Co. | db876d34-1af9-4e0a-9e9a-32a8b00e9405 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE | Old East Main Co. | 2ea288fe-815d-4568-9592-55ea428448fa | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | cea1c223-c9d4-42ac-8c5b-c0ca647d57a1 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Old East Main Co. | 00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 8f4a6a31-2fae-42fe-924f-10237c59e791 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ef48288b-533f-4924-ba12-fc8cb83643d4 | 2026-03-02 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | e6976bf4-ad77-4953-858f-4a0ec7f4300c | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | b3d2da09-d9c9-4c27-82fe-a434ece2f099 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ba9331ef-3744-4072-80a2-af95c6f7ee05 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 1a53d8d5-e650-4825-8a3b-7cf42c36e3e5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 086dfda5-9fe7-46b4-9964-4977b86cfdd5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ce9a2139-c5c2-43e2-bd51-1f14ace594d9 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Bask SPF 40 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Surfside Skincare, Inc. dba Bask Suncare | 49a30877-e39f-46a3-e063-6394a90a8dd2 | 2026-03-02 | Warnings | M020 |
| Sunscreen SPF30 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | f6014a97-12d3-4f42-86de-866a206c6c06 | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30V | SPF30 BS VANILLA | Epic Laboratories, LLC | 02488aad-28be-4ffb-e063-6294a90ad01e | 2026-03-02 | 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 |