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 |
|---|---|---|---|---|---|---|
| Tinted Sheer Mineral Zinc Sunscreen | ZINC OXIDE | SKIN THERAPY PLLC | 397130ea-dfad-ecd3-e063-6394a90a7da4 | 2025-12-12 | M020 | |
| Tinted Sheer Mineral Zinc Sunscreen | ZINC OXIDE | SKIN THERAPY PLLC | 39716532-a699-63b7-e063-6294a90aa0f0 | 2025-12-12 | M020 | |
| Sun Elegant Mineral Sunscreen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | SKIN BY NESRIN | 3580ae10-1867-cb68-e063-6394a90a72df | 2025-12-12 | M020 | |
| Simply Zinc Mineral Sunscreen Tinted | ZINC OXIDE | SKIN BY NESRIN | 3580da4f-116d-8108-e063-6294a90a7bf4 | 2025-12-12 | M020 | |
| PROTECTOR SOLAR NON-TINTED SPF SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | The Beez Kneez Skin Care & Acne Clinic LLC | 358195c0-6d28-1ffe-e063-6394a90a6027 | 2025-12-12 | M020 | |
| PROTECTOR SOLAR TINTED SPF SUNSCREEN | ZINC OXIDE | The Beez Kneez Skin Care & Acne Clinic LLC | 3581d973-ac0b-7d2e-e063-6294a90ae2b3 | 2025-12-12 | M020 | |
| Matte Velvet Tint | TITANIUM DIOXIDE, ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 3583f860-664b-2658-e063-6394a90a3857 | 2025-12-12 | M020 | |
| Satin Tint | ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 35920108-7f8a-27d4-e063-6294a90a0ef6 | 2025-12-12 | M020 | |
| SPF Lip | TITANIUM DIOXIDE, ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 359297cd-10e2-6ddd-e063-6394a90a4aa0 | 2025-12-12 | M020 | |
| Matte Velvet Tint | TITANIUM DIOXIDE, ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 359641c5-0e19-f243-e063-6394a90aeebc | 2025-12-12 | M020 | |
| Satin Tint | ZINC OXIDE | Brent Loftis, D.O., Inc., A California Medical Corporation | 359684cf-ca11-f9af-e063-6394a90ac4c1 | 2025-12-12 | M020 | |
| TINTED MINERAL SUNSCREEN SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | DERMATOLOGY ARTS | 35814d5d-fd34-05b3-e063-6294a90aadd1 | 2025-12-12 | M020 | |
| JAYSUING Rice Probiotics Sunscreen | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 45cdc741-9ce0-fd6c-e063-6294a90adc0b | 2025-12-12 | Warnings | M020 |
| Tinted Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA HAIR DESIGN | 36eb4cd3-778c-362f-e063-6294a90a059c | 2025-12-11 | M020 | |
| Matte Finish | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37630c6c-f768-7b3e-e063-6394a90af565 | 2025-12-11 | M020 | |
| Signature Tint SPF 40 | ZINC OXIDE | ADVANCED AESTHETICS SKIN CARE STUDIO, INC | 348f1bd3-1245-2d9a-e063-6394a90a4787 | 2025-12-11 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | ADVANCED AESTHETICS SKIN CARE STUDIO, INC | 348fcc63-d8e3-90a1-e063-6294a90ade11 | 2025-12-11 | M020 | |
| Tinted Sunscreen | ZINC OXIDE | Scottsdale Skin Boutique and Dermatology Pllc | 34a54441-c741-0c46-e063-6294a90a9be8 | 2025-12-11 | M020 | |
| Instant Glow | ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37620171-140d-e096-e063-6294a90af93b | 2025-12-11 | M020 | |
| Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Scottsdale Skin Boutique Aesthetics Pllc | 34a49563-c74b-2fd1-e063-6394a90a6c56 | 2025-12-11 | 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 |