Zinc Oxide 20.00%
- Product NDC
- 85033-001
- 11-digit product format
- 850330001
- Labeler code
- 85033
- Product ID
- 85033-001_514002f3-7bef-9313-e063-6394a90a4c3e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SPF 50 Mineral
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Coconut Caliente Costa Rica LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-10
- Substance
- ZINC OXIDE
- Active strength
- 20 g/100mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zinc Oxide 20.00%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 20 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85033-001-04 | Zinc Oxide 20.00% | 177 mL in 1 TUBE | LOTION | 177 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85033-001-04 | 85033000104 | 177 mL in 1 TUBE (85033-001-04) | 177 ml | 2025-10-10 | No | No | Historical |