Broad Spectrum SPF45
- Product NDC
- 83286-014
- 11-digit product format
- 832860014
- Labeler code
- 83286
- Product ID
- 83286-014_4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Octinoxate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Drmtlgy, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-01
- Substance
- OCTINOXATE; ZINC OXIDE
- Active strength
- 7.5; 12 g/100mL; 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
- Broad Spectrum SPF45
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCTINOXATE | 7.5 g/100mL |
| ZINC OXIDE | 12 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4Y5P7MUD51, SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83286-014-01 | Broad Spectrum SPF45 | 50 mL in 1 BOTTLE | GEL | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83286-014 | BROAD SPECTRUM SPF45 (ZINC OXIDE, OCTINOXATE) GEL [DRMTLGY, LLC] | 1 | Current NDC, 1 package rows | 20250508_0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83286-014-01 | 83286001401 | 50 mL in 1 BOTTLE (83286-014-01) | 50 ml | 2025-05-01 | No | No | Current |