Ultra Sunscreen
- Product NDC
- 85448-003
- 11-digit product format
- 854480003
- Labeler code
- 85448
- Product ID
- 85448-003_4ed974b8-6c12-08e0-e063-6294a90a7713
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octinoxate, Octisalate, Titanium Dioxide
- Dosage form
- EMULSION
- Route
- TOPICAL
- Labeler
- Jiangsu Senwo Medical Technology Co., Ltd.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-07
- Substance
- OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
- Active strength
- .09; .035; .027 g/mL; g/mL; g/mL
- 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
- Ultra Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | .09 g/mL |
| OCTISALATE | .035 g/mL |
| TITANIUM DIOXIDE | .027 g/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4ed974b8-6c11-08e0-e063-6294a90a7713 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85448-003-01 | Ultra Sunscreen | 473 mL in 1 BOTTLE | EMULSION | 473 | 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 |
|---|---|---|---|---|---|---|
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bad1502-bc44-54ec-e063-6294a90ace8b | 2026-02-25 | Warnings | M020 |
| Truskin SPF 30 Mineral Sunscreen Facial Serum | ZINC OXIDE | Allure Labs | 2e20c132-8a03-1d5d-e063-6394a90ad2c3 | 2026-02-25 | Warnings | M020 |
| Rationale The Brilliance Tinted Serum SPF 50 | ZINC OXIDE | RATIONALE GROUP PTY LTD | 5c38506b-1533-435f-87a6-0452bae5b29f | 2026-02-24 | Warnings | M020 |
| FULLY RICE CERAMIDE MOISTURE SUNSCREEN | ZINC OXIDE | Adapt Inc. | d8bfe222-3184-4c98-9876-ef5ac81772b6 | 2026-02-24 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N M O20 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 9507f6d1-c11c-428d-8d95-b436f27ba26a | 2026-02-24 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b93538a-3b3e-90f7-e063-6294a90ab898 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b93cd22-1289-29bc-e063-6294a90ab781 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b943d72-dcde-e2e4-e063-6294a90ab7c4 | 2026-02-24 | Warnings | M020 |
| ANTI-AGING NON-TINTED SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | LASER GIRL SKINCARE, LLC | 4b946c39-718b-d70e-e063-6394a90a0db8 | 2026-02-24 | Warnings | M020 |
| Reunited Lipgloss SPF 30 - BTCH IS BACK | HOMOSALATE, OCTOCRYLENE, OCTISALATE | Princeville Productions, LLC, DBA Reunited Beauty | 4b961531-fbca-d1cf-e063-6294a90ab9a1 | 2026-02-24 | Warnings | M020 |
| sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 8f5e634c-765b-4ffe-bb12-753d64c90cf9 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | e97bf30a-1465-4912-bd55-1e7dd993132b | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 67efcd94-00af-477b-bd14-d1c7b95d305a | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3f3d2e1e-1e95-4719-8ca9-83b6b804ab9f | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Sheer Touch Sunscreen Mist SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | f642788c-3643-459a-b736-0c06d0cd32a9 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 95ba2b33-f593-4e95-bd6e-5910d6aa5158 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 3b85004a-8832-4eac-bd70-1e607ae7af4b | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 7f0fc23b-2d70-4426-9d64-a6d2b643309f | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | 0ae9edd8-bf76-4bb2-ab78-c43c017ba4a5 | 2026-02-24 | Warnings, Adverse reactions | M020 |
| Avbenzone, Homosalate, Octisalate | AVBENZONE, HOMOSALATE, OCTISALATE | Meijer, Inc. | f8960995-66b6-4197-8976-b318fe01488f | 2026-02-24 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85448-003-01 | 85448000301 | 473 mL in 1 BOTTLE (85448-003-01) | 473 ml | 2026-04-07 | No | No | Current |