DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted
- Product NDC
- 82240-424
- 11-digit product format
- 822400424
- Labeler code
- 82240
- Product ID
- 82240-424_09e30a62-356e-3cff-e063-6394a90a270f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TITANIUM DIOXIDE, ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- DERMAKA SKIN PRODUCTS
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-02
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 60; 110 mg/mL; mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 60 mg/mL |
| ZINC OXIDE | 110 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 15FIX9V2JP, SOI2LOH54Z |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82240-424-00 | DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted | 100 mL in 1 TUBE | CREAM | 100 | 2 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82240-424-00 | 82240042400 | 100 mL in 1 TUBE (82240-424-00) | 100 ml | 2023-10-02 | No | No | Historical |