PRVWORA Ultra Defense Sunscreen
- Product NDC
- 87482-001
- 11-digit product format
- 874820001
- Labeler code
- 87482
- Product ID
- 87482-001_4e9f781d-6b07-b69a-e063-6394a90a36c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Octinoxate, Octisalate, Octocrylene
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cellarkbio Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-04
- Substance
- AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 28.5; 72.5; 45; 95 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRVWORA Ultra Defense Sunscreen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 28.5 mg/mL |
| OCTINOXATE | 72.5 mg/mL |
| OCTISALATE | 45 mg/mL |
| OCTOCRYLENE | 95 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W, 5A68WGF6WM |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87482-001-01 | PRVWORA Ultra Defense Sunscreen | 50 mL in 1 TUBE | CREAM | 50 | | 1 |
| 87482-001-02 | PRVWORA Ultra Defense Sunscreen | 1 in 1 CARTON | CREAM | 1 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87482-001-01 | 87482000101 | 50 mL in 1 TUBE | 50 ml | | | | Historical |
| 87482-001-02 | 87482000102 | 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) | 1 tube | 2026-04-04 | No | No | Current |