5281 SUNSCREEN
- Product NDC
- 76138-219
- 11-digit product format
- 761380219
- Labeler code
- 76138
- Product ID
- 76138-219_1cee97c2-00a1-c8b8-e063-6294a90ac4c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octocrylene, Octisalate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Innovation Specialties
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-05-10
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 5281 SUNSCREEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 100 mg/mL |
| OCTISALATE | 50 mg/mL |
| OCTOCRYLENE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76138-219-05 | 5281 SUNSCREEN | 15 mL in 1 BOTTLE | LOTION | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76138-219 | 5281 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240712_86fc4539-e1c5-4d0f-a418-f48729cb2b20.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76138-219-05 | 76138021905 | 15 mL in 1 BOTTLE (76138-219-05) | 15 ml | 2022-05-10 | 0000-00-00 | No | No | Current |