Tinted Mineral Sunscreen
- Product NDC
- 85585-203
- 11-digit product format
- 855850203
- Labeler code
- 85585
- Product ID
- 85585-203_46161253-7b9f-afb1-e063-6394a90a64d5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-30
- Substance
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 mg/g; mg/g
- 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
- Tinted Mineral Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 38 mg/g |
| TITANIUM DIOXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 36c0400b-8ad9-654b-e063-6294a90ad040 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85585-203-15 | Tinted Mineral Sunscreen | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85585-203-50 | Tinted Mineral Sunscreen | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
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 |
|---|---|---|---|---|---|---|
| Eucerin Sensitive Mineral Face Sunscreen SPF 35 | ZINC OXIDE 24% | Beiersdorf Inc | f3a8bb6b-f051-5d39-e053-2a95a90adafc | 2025-12-31 | Warnings | M020 |
| Coppertone Limited Edition Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | f41e09bf-407d-65a4-e053-2a95a90a2436 | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Hydragel SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdort Inc | b5f7cacb-92b9-a6b7-e053-2a95a90aea02 | 2025-12-31 | Warnings | M020 |
| Eucerin Advanced Hydration Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | cd6112fe-89e4-a79b-e053-2a95a90ad7f4 | 2025-12-31 | Warnings | M020 |
| Eucerin Age Defense SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdort Inc | cd9d4f30-fb37-9935-e053-2995a90a9936 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 70 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | cc5d1f9b-2c8a-1392-e053-2a95a90acb9e | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Brightening Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23e368db-4b2f-d23b-e063-6394a90a1f06 | 2025-12-31 | Warnings | M020 |
| Eucerin Advanced Hydration Ultra-Light Face Sunscreen SPF 50 | AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 25d9c520-431a-5546-e063-6394a90a4e0d | 2025-12-31 | Warnings | M020 |
| Eucerin Advanced Hydration Sunscreen SPF 30 | (TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | 1273012a-107c-1b19-e063-6394a90a53e4 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23e5bf2c-88c2-d346-e063-6394a90abc78 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23fb728a-8c11-d041-e063-6294a90abb55 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sport Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | c0421c97-72bd-fcac-e053-2995a90aac28 | 2025-12-31 | Warnings | M020 |
| Coppertone Defend and Clear | OCTINOXATE, OCTISALATE, ZINC OXIDE | Beiersdorf Inc | baaec6a9-2c60-2d11-e053-2a95a90abca7 | 2025-12-31 | Warnings | M020 |
| Coppertone Pure and Simple Sunscreen SPF 50 | ZINC OXIDE 24.08% | Beiersdorf Inc | b6492438-5dd2-030e-e053-2a95a90a2f9f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdort Inc | ca8d2e20-c1f1-ecf2-e053-2a95a90a790f | 2025-12-31 | Warnings | M020 |
| Eucerin Tinted Age Defense Suncreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 125d053c-9418-5772-e063-6294a90a6d6d | 2025-12-31 | Warnings | M020 |
| Coppertone Sport SPF 15 Sunscreen | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | cc4812da-0686-7789-e053-2995a90a561f | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Mineral Sunscreen SPF 50 | ZINC OXIDE | Beiersdorf Inc | b6861830-fdad-3829-e053-2a95a90a0971 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Tear Free Mineral Sunscreen SPF 50 | OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5% | Beiersdorf Inc | c054fd86-b0d9-24fc-e053-2a95a90aea2c | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 70 | AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | c0552256-d8cb-5473-e053-2995a90ad0d5 | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85585-203-15 | 85585020315 | 1.5 g in 1 PACKET (85585-203-15) | 1.5 g | 2021-03-23 | Yes | No | Current |
| 85585-203-50 | 85585020350 | 53 g in 1 BOTTLE, PUMP (85585-203-50) | 53 g | 2025-05-30 | No | No | Current |