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 |
|---|---|---|---|---|---|---|
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 22aa46af-5d0f-4256-8f45-be06f6627561 | 2026-08-10 | Warnings | M020 |
| Colorescience Total Protection No Show Mineral Body Shield | ZINC OXIDE | Colorescience | 52e1f59e-63cb-7480-e063-6394a90ad7c5 | 2026-08-10 | Warnings | M020 |
| Eucerin Radiant Tone Tinted Sunscreen SPF 50 | AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 596a4204-3d29-9023-e063-6294a90ad99e | 2026-08-10 | Warnings | M020 |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Merz North America, Inc. | d4d4bfcf-3674-4847-8ad8-1716a8e821ae | 2026-08-10 | Warnings | M020 |
| ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen | BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE | Grace and Fire USA Inc. | 56ad0dce-410e-9d78-e063-6294a90a1c3e | 2026-08-09 | Warnings | M020 |
| ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen | ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE | Guangzhou Yapheon Health Industry Co., Ltd. | 552a36ed-7a66-4048-e063-6394a90a09bc | 2026-08-08 | Warnings | M020 |
| lip balm SPF15( 2533) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5870aa44-1375-cdc5-e063-6394a90af4a5 | 2026-08-07 | Warnings | M020 |
| lip balm SPF15( Zinc oxide) 01 | ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5871ab1d-cf07-d737-e063-6394a90a58fe | 2026-08-07 | Warnings | M020 |
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58636012-7e29-7206-e063-6394a90a83e9 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864275d-a480-06f8-e063-6394a90aecab | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864881c-c495-1f32-e063-6294a90a1304 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Elta MD UV Daily Peptide Lip Balm SPF 40 | ZINC OXIDE | CP Skin Health Group, Inc | 945538b5-5745-42cf-b610-0018ca2ec254 | 2026-08-06 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58653d79-8fff-f319-e063-6294a90af7a3 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5865f0e5-14b2-c4bf-e063-6294a90a4710 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Stream2Sea Ecostock SPF 40 Sunscreen | ZINC OXIDE | Stream2Sea, LLC | 5866e026-a652-3300-e063-6394a90acff0 | 2026-08-06 | Warnings | M020 |
| NHLMA Skin Defense Sunscreen | BROAD SPECTRUM SPF 30 | NATIONAL HAIR LOSS LLC | 56326ae0-387f-ad08-e063-6294a90acc4f | 2026-08-06 | Warnings | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | M020 |
| Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Kenvue Brands LLC | 129ae274-0094-be5e-e063-6394a90a9801 | 2026-08-05 | Warnings | M020 |
| Leader Kids Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 3636693a-ba81-5d49-e063-6394a90a3006 | 2026-08-05 | Warnings | 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 |