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 |
|---|---|---|---|---|---|---|
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d838-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Light | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | fbbff4eb-a63e-b083-e053-6294a90a404a | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c6035e-c179-b3e6-e063-6394a90a86cd | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c618ae-3d4d-8c87-e063-6394a90a5396 | 2024-12-26 | Warnings | M020 |
| KOPARI Sun Shield Soft Glow Daily Face SPF30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d436d06-3f81-b4a6-e063-6294a90aa635 | 2024-12-26 | Warnings | M020 |
| NEORA Invisibloc Sunscreen Gel Broad Spectrum SPF40 | AVOBENZONE, HOMOSALATE, OCTISALATE | COSMAX USA, CORPORATION | 0d584736-3f55-2542-e063-6294a90af3cf | 2024-12-26 | Warnings | M020 |
| NARS Radiance Primer Broad Spectrum SPF 35 Sunscreen | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d59d9cb-c891-1097-e063-6394a90a806e | 2024-12-26 | Warnings | M020 |
| KOPARI Sun Shield Soft Glow Daily Face SPF30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d3673da-822b-09e2-e063-6394a90a348e | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c61c42-eddb-1ebd-e063-6294a90aee13 | 2024-12-26 | Warnings | M020 |
| GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE | COSMAX USA, CORPORATION | 0d438692-cd83-ea42-e063-6394a90a862d | 2024-12-26 | Warnings | M020 |
| KOPARI Antioxidant Face Shield Mineral SPF 30 | ZINC OXIDE | COSMAX USA, CORPORATION | 0d43e22c-5e3d-df90-e063-6294a90aac2b | 2024-12-26 | Warnings | M020 |
| NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30 | TITANIUM DIOXIDE, ZINC OXIDE | COSMAX USA, CORPORATION | 0d489154-6168-977e-e063-6394a90aa609 | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Fair | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | fbbfa61a-cbb4-3104-e053-6394a90a832f | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to dark | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | e6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to Medium | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | fbc05ceb-2e6b-3c37-e053-6394a90ac4f4 | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | fbc0ff10-fb2f-e637-e053-6294a90a0c29 | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | 2984c64f-eaac-ecb6-e063-6394a90aeb12 | 2024-12-26 | Warnings | M020 |
| Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | 2984a014-a56f-753b-e063-6294a90a13f5 | 2024-12-26 | Warnings | M020 |
| Julep No Excuses Gel for Face SPF40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | 298404c4-d4be-7395-e063-6294a90a86bf | 2024-12-26 | Warnings | M020 |
| Cover FX Invisible Primer SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmax Usa, Corporation | 2983dd7c-7ca7-e952-e063-6394a90a3098 | 2024-12-26 | 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 |