Powder
- Product NDC
- 61354-119
- 11-digit product format
- 613540119
- Labeler code
- 61354
- Product ID
- 61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
- 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
- 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 |
|---|---|
| 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 |
|---|---|
| 08b8003f-40be-3380-e063-6294a90a4f6b | 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 |
|---|---|---|---|---|---|---|
| 61354-119-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | 3 | |
| 61354-119-02 | Powder | 1 in 1 CARTON | POWDER | 1 | 3 |
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 |
|---|---|---|---|---|---|---|
| Mary Kay Foundation Primer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Mary Kay Inc. | 59d25b44-1adb-4790-8ce6-2d847a06b8b3 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm The Go Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | cf7fb8f0-483d-443b-b381-086a255f0783 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm Sampler Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | 0a9ee359-19c1-4266-8a51-a68f655de151 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | d459e2f7-dc78-4519-9733-01495fc447a2 | 2024-12-17 | Warnings | M020 |
| Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | 2982ce67-f136-b93b-e063-6394a90a81ac | 2024-12-17 | Warnings | M020 |
| AHAVA Protecting Body Broad Spectrum SPF 30 | AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | e188c328-3617-4f02-8bc9-47976acf3711 | 2024-12-17 | Warnings | M020 |
| Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc | a1cab79d-0151-49ee-86dc-c2739842e62e | 2024-12-17 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b | 2024-12-17 | Warnings | M020 |
| Even Up Sunscreen SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f9d375af-3c8b-4462-b729-fdd4be929284 | 2024-12-17 | Warnings | M020 |
| ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 | ZINC OXIDE | 9055-7588 Quebec Inc. DBA Attitude | 0d842103-7157-793a-e063-6394a90a6feb | 2024-12-16 | Warnings | M020 |
| SPF15 natural lip balm 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 295f2a15-19fa-011f-e063-6394a90aea7b | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | Bobbi Brown Professional Cosmetics Inc. | 4bfbfac7-6738-4996-a152-95dfbd759154 | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 | OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | dc6b28ca-b922-460a-8028-fb3f5afdbe9d | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 | OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | 1f9a4b71-45aa-4156-9fe6-ffa81f808a85 | 2024-12-16 | Warnings | M020 |
| AHAVA Protecting Moisturizing SPF50 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 7502e06d-754b-4cb8-ba4c-91eee0453932 | 2024-12-16 | Warnings | M020 |
| Natural Finish Pressed Foundation SPF 20 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c389e183-bfad-4813-af09-fae3aa05e82a | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Brush-On Shield SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c77357f1-7ada-4325-86f7-5ee801610f42 | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 | ZINC OXIDE | Colorescience | 5b6f906e-6620-48b0-9c39-0eb1c8dc1c63 | 2024-12-16 | Warnings | M020 |
| Ryshi SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Rite Aid | e313350f-74d9-370b-e053-2995a90aeeaf | 2024-12-15 | Warnings | M020 |
| Annmarie SPF 20 Sunscreen | ZINC OXIDE 15% | Annmarie Gianni Skin Care LLC | cc722ce1-0ded-19d5-e053-2995a90a7d03 | 2024-12-15 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61354-119-01 | 61354011901 | 100 mg in 1 CUP | 100 mg | Historical | |||
| 61354-119-02 | 61354011902 | 1 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01) | 1 cup | 2023-10-27 | No | No | Current |