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 |
|---|---|---|---|---|---|---|
| MEDICUBE PDRN SILKY SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | APR US INC | 57154bec-6714-0314-e063-6294a90a4bd0 | 2026-07-20 | Warnings | M020 |
| TOCOBO Double UV Defense Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON Co., Ltd. | 56aff65a-aa08-dc3f-e063-6294a90acac3 | 2026-07-19 | Warnings | M020 |
| THE SPORTO Invisible Sport for Body | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 46564a09-909d-bcc7-e063-6294a90a627b | 2026-07-17 | Warnings | M020 |
| RR Sun Creme | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | dc60b685-a7fc-47bb-ade9-44a8e3b54812 | 2026-07-17 | Warnings | M020 |
| Cetaphil Tinted Daily Facial Moisturizer SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Galderma Laboratories, L.P. | 0ef2ebae-7198-47f4-8891-d1ca3cf54d4b | 2026-07-16 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | PMI Branded Pharmaceuticals, Inc. | f9be5adb-dce3-4b17-939f-d80d486f2cb0 | 2026-07-16 | Warnings | M020 |
| BaseLife Pure Mineral Shield Sunscreen | ZINC OXIDE | Wintech America, Inc. | 7f741a91-6ed8-4d08-9196-d15527d044d5 | 2026-07-15 | Warnings | M020 |
| BaseLife Clear UV Defense Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wintech America, Inc. | 128db446-93ba-4347-bd39-66177572c659 | 2026-07-15 | Warnings | M020 |
| Biore Aqua Rich Facial Mist SPF 50 | OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE | Kao USA Inc. | 56a80a0d-b0b5-1098-e063-6294a90a5270 | 2026-07-15 | Warnings | M020 |
| Anti Aging Lip Balm Pot SPF 15 | LIP BALM | Epicuren Disocovery | 4097e28a-ed11-e16a-e063-6294a90a5e9b | 2026-07-14 | Warnings | M020 |
| HolyCow Mineral Tallow Sunscreen Face and Body SPF 50 | ZINC OXIDE | CALM ENTERPRISE LLC | 722462d8-d2ab-44ce-9065-673ab2076269 | 2026-07-14 | Warnings | M020 |
| X-Treme Cream Propolis Sunscreen SPF 45 | X-TREME CREAM | Epicuren Discovery | 3b29976e-eee0-b978-e063-6294a90accd6 | 2026-07-14 | Warnings | M020 |
| Anti-Aging Lip Balm SPF 15 | LIP BALM | Epicuren Discovery | 3cbd0550-b6e5-3e86-e063-6394a90ac07f | 2026-07-14 | Warnings | M020 |
| Zinc Oxide Perfecting Sunscreen | ZINC OXIDE | Epicuren Discovery | 1a0228f9-bf3f-a1fe-e063-6294a90a3fb5 | 2026-07-14 | Warnings | M020 |
| Vacation Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 14b8a3cf-031c-4c52-ba81-e683e69d0f37 | 2026-07-14 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | L. Perrigo Company | bd5c9df7-8dfb-4d20-9966-e148c5667b22 | 2026-07-14 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 4081a4ad-b738-5fb6-e063-6394a90a9171 | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc5c1d8-91f8-8ad2-e063-6294a90a9229 | 2026-07-13 | Warnings | M020 |
| Olay Super Serum Body Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 5513c5e2-3baf-2f09-e063-6394a90a495a | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc48592-f70d-664e-e063-6294a90ac6e8 | 2026-07-13 | 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 |