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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30 | OCTOCRYLENE, AND ZINC OXIDE | The Procter & Gamble Manufacturing Company | f6801575-6081-7566-e053-2995a90a20a8 | 2025-12-18 | Warnings | M020 |
| Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 00280745-908b-468f-e063-6294a90aa12f | 2025-12-18 | Warnings | M020 |
| OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 10bd41ac-9b96-840d-e063-6394a90a98d9 | 2025-12-18 | Warnings | M020 |
| Olay Glow plus Protect Sunscreen Dewy Glow SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | The Procter & Gamble Manufacturing Company | 10bc4127-7569-d0de-e063-6294a90a97bf | 2025-12-18 | Warnings | M020 |
| First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 29645d90-a444-4090-e063-6294a90ac7e3 | 2025-12-18 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Tan Golden | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 46440bac-de69-e59c-e063-6394a90a76c0 | 2025-12-18 | Warnings | M020 |
| FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen | ZINC OXIDE | DONG WHA PHARM. CO., LTD. | 46457c78-74d6-ea6a-e063-6294a90a24ac | 2025-12-18 | Warnings | M020 |
| THE MUG GUARD Invisible Gel Suncare for Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 4646988c-1060-ed5f-e063-6394a90aa765 | 2025-12-18 | Warnings | M020 |
| Sage and Zinc Facial Hydrating SPF15 | ZINC OXIDE | Emeis Cosmetics Pty Ltd | ccabd647-ecdd-7230-e053-2a95a90a7a96 | 2025-12-18 | Warnings | M020 |
| Avail Facial Sunscreen SPF 25 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Emeis Cosmetics Pty Ltd | 7be903e4-5f07-35b2-e053-2991aa0a1340 | 2025-12-17 | Warnings | M020 |
| Mineral Sheer Stick | ZINC OXIDE | Supergoop, LLC | 0beed72e-51df-d15a-e063-6394a90af559 | 2025-12-17 | Warnings | M020 |
| Sunscreen Lotion118ml | ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5% | Foshan Sugar Max Cosmetics CO.,Ltd | 4620c41a-2188-00f5-e063-6394a90a613c | 2025-12-17 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 46224dbe-a0fb-c242-e063-6394a90a2634 | 2025-12-17 | Warnings | M020 |
| CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N | ENSULIZOLE, OCTISALATE | Parfums Christian Dior | 31141a45-54e2-4463-ab42-4df56d911650 | 2025-12-17 | Warnings | M020 |
| Perricone High Potency Face Finishing and Firming Moisturizer | TITANIUM DIOXIDE, ZINC OXIDE | THG Beauty USA LLC | 2409cea1-7077-dc12-e063-6294a90a4558 | 2025-12-17 | Warnings | M020 |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635a073-5484-f96c-e063-6394a90adef5 | 2025-12-17 | M020 | |
| Mineral Sunscreen Lip | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 36362dc7-31d7-f766-e063-6294a90a129b | 2025-12-17 | M020 | |
| Mineral Sunscreen Non-Tinted | ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635e45b-6978-ac69-e063-6294a90a22ac | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 36480f7f-37e8-decd-e063-6394a90ada60 | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 364827bd-5781-eb53-e063-6394a90ab22f | 2025-12-17 | 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 |