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
- 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Intense Therapy Lip Balm Basil Lemon | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 277cb44d-608a-4ffc-a2a5-ac57d33d214c | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Black Cherry | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 8f413bd6-258c-4c3c-89d1-369938c85720 | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Cucumber Lime | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 5f15bee9-9bf4-4f27-a6b5-4205deb625f6 | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Winter Melon | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | e7792b4e-a6d2-487e-ba28-27b68e6d7e27 | 2026-09-08 | Warnings | M020 |
| Jack Black Intense Therapy Lip Balm Vanilla Bourbon | AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN | Jack Black, LLC | 517040d1-e6ed-40ca-a46f-2f75403dbc3c | 2026-09-08 | Warnings | M020 |
| Intense Therapy Lip Balm Mango and Mandarin | SUNSCREEN SKIN PROTECTANT LIP BALM | Jack Black, LLC | 8c55d1cd-cdd6-468b-8a17-b940c6210116 | 2026-09-08 | Warnings | M020 |
| Jack Black Intensive Therapy Lip Balm Mango Chili Lime | AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN | Jack Black, LLC | 51349d57-b14d-4798-8d68-03fbe3713d1e | 2026-09-08 | Warnings | M020 |
| Jack Black Sun Guard Sunscreen SPF45 | SUNSCREEN | Jack Black, LLC | 3cc86bb2-05ce-47eb-8c71-f4f116ca5840 | 2026-09-08 | Warnings | M020 |
| Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter | LIP BALM SUNSCREEN | Jack Black, LLC | 518cb17a-fdaa-4a60-93fc-708305366eb8 | 2026-09-08 | Warnings | M020 |
| Jack Black Lavender Lip Balm 0.25oz | LIP BALM SUNSCREEN | Jack Black, L.L.C. | e8c6a6d9-1093-41f1-87d5-faf8583d4319 | 2026-09-08 | Warnings | M020 |
| SPF15 lip balm 01 | OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | f8695305-b89d-c21c-e053-6394a90a0e84 | 2026-09-08 | Warnings | M020 |
| Sunscreen stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | e9f963ee-a98c-efc1-e053-2a95a90aaf53 | 2026-09-08 | Warnings | M020 |
| SPF30 Sunscreen 01 | AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5b04751d-32e9-a7e2-e063-6294a90aefbd | 2026-09-08 | Warnings | M020 |
| Juyasuyon Invisible Sunscreen | HOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONE | Guangdong Aimu Biological Technology Co., Ltd | 5ab335b5-bb9e-4642-e063-6294a90a3986 | 2026-09-05 | Warnings | M020 |
| No7 Future Renew Defense Shield SPF 50 | AVOBENZONE, OCTINOXATE, OCTISALATE | BCMC | 41cc2c52-c6a4-611c-e063-6294a90aae01 | 2026-09-03 | Warnings | M020 |
| WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALMART, INC. | 58b5d0ce-9157-9dee-e063-6394a90ab543 | 2026-09-02 | Warnings | M020 |
| Chantecaille Ultra Sun Protection Sunscreen SPF 45 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Chantecaille Beaute Inc | 6186ea56-7d56-43f5-985d-a012f1296afa | 2026-09-02 | Warnings | M020 |
| ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50 | AVOBENZONE, BEMOTRIZINOL, OCTISALATE | Grace and Fire USA | 5739c5b9-00d8-75a8-e063-6394a90aa8c7 | 2026-09-01 | Warnings | M020 |
| Sun Wave Anti Aging Insta Dry SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Life Brands, LLC | 2d5fa597-08a8-41ca-ba9e-b52e41a5c70c | 2026-09-01 | Warnings | M020 |
| Sunski Hot Block Mineral Sunscreen Stick SPF 50 | ZINC OXIDE | Stewart Charley Ventures LLC dba Sunski | 04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8 | 2026-09-01 | 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 |