Tinted Mineral Sunscreen
- Product NDC
- 85376-203
- 11-digit product format
- 853760203
- Labeler code
- 85376
- Product ID
- 85376-203_46282510-d211-8afa-e063-6294a90af8d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- HSC MIAMI, INC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-27
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tinted Mineral Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15FIX9V2JP, SOI2LOH54Z |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85376-203-15 | Tinted Mineral Sunscreen | 15 g in 1 PACKET | CREAM | 15 | | 2 |
| 85376-203-50 | Tinted Mineral Sunscreen | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85376-203-15 | 85376020315 | 15 g in 1 PACKET (85376-203-15) | 15 g | 2025-01-27 | Yes | No | Historical |
| 85376-203-50 | 85376020350 | 53 g in 1 BOTTLE, PUMP (85376-203-50) | 53 g | 2025-01-27 | No | No | Historical |