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 |
|---|---|---|---|---|---|---|
| NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30 | ZINC OXIDE | LABORATOIRES DRUIDE INC | 19af4441-31b2-72db-e063-6394a90a813c | 2026-01-14 | Warnings | M020 |
| Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 | ZINC OXIDE | Sqween LLC | 9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486 | 2026-01-14 | Warnings | M020 |
| SCENTUAL AROMA BEAUTY SUN VEIL SPF30 | TITANIUM DIOXIDE, ZINC OXIDE | LABORATOIRES DRUIDE INC | 0799ac38-9a41-6579-e063-6394a90ac4b6 | 2026-01-14 | Warnings | M020 |
| NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30 | ZINC OXIDE | LABORATOIRES DRUIDE INC | 0b412e24-baf6-e68e-e063-6394a90a5f49 | 2026-01-14 | Warnings | M020 |
| Dr. C. Tuna Sun Stick SPF 50 | AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | fc89d1b5-1ffe-4f06-8c5c-31f2eb0b5641 | 2026-01-14 | Warnings | M020 |
| Oiana Mineral Sunscreen Drops | ZINC OXIDE | Oiana LLC | 4860257d-a8bf-7ce5-e063-6394a90a74db | 2026-01-14 | Warnings | M020 |
| Standard Procedure Lip Balm SPF 50 | ZINC OXIDE HOMOSALATE OCTOCRYLENE | Standard Procedure Inc | 1e3db995-b1c5-3a2e-e063-6294a90af75e | 2026-01-14 | Warnings | M020 |
| Standard Procedure SPF 50 Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Standard Procedure Inc | 1d3f87de-90c0-75c0-e063-6394a90a2ef4 | 2026-01-14 | Warnings | M020 |
| EELHOE Bio Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 48654406-505b-518b-e063-6394a90a5add | 2026-01-14 | Warnings | M020 |
| JAYSUING Hyaluronic Acid Moisturizing Sunscreen | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 48662fae-2d41-4a4a-e063-6394a90a1522 | 2026-01-14 | Warnings | M020 |
| CALIFORNIA ALOE FRESH POW DERY SUN | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | NATURE REPUBLIC CO., LTD. | aa10dbbf-97b3-4258-bbd3-0d8cc9935e12 | 2026-01-13 | Warnings | M020 |
| COSRX | VITAMIN E VITALIZING SUNSCREEN | COSRX inc. | 4840f608-944a-3e3d-e063-6394a90a1d9d | 2026-01-13 | Warnings | M020 |
| Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 Plus | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | b043f0f3-b263-4c49-86ca-9ecc71a22aa8 | 2026-01-13 | Warnings | M020 |
| ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30 | ZINC OXIDE | New Frontier Bio, Inc | ef6c8443-fd10-2022-e053-2a95a90a45ea | 2026-01-13 | Warnings | M020 |
| Bluevado Sunfix | ZINC OXIDE, TITANIUM DIOXIDE | Magic Blue, LLC | 2e5315bf-39f4-401c-8207-18ef6a97e024 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e20f5dc9-e863-b090-e053-2a95a90a5044 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical Clear SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | 1305fa94-47d5-7a42-e063-6394a90a0aba | 2026-01-13 | Warnings | M020 |
| Intellishade Clear SPF 50 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE | Revision, LLC | e213b46d-d061-dc83-e053-2995a90ad875 | 2026-01-13 | Warnings | M020 |
| Intellishade Matte SPF 45 | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e213ae87-4db2-3070-e053-2995a90a083b | 2026-01-13 | Warnings | M020 |
| Sun Project Moisture | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE | THANK YOU FARMER CO., LTD | 20a83f02-d851-4aac-e063-6394a90ae1a6 | 2026-01-13 | 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 |