Drops
- Product NDC
- 80641-013
- 11-digit product format
- 806410013
- Labeler code
- 80641
- Product ID
- 80641-013_2e99f7af-047a-769c-e063-6394a90a1406
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone Octisalate Octocrylene
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Vacation Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-07
- Substance
- AVOBENZONE; OCTISALATE; OCTOCRYLENE
- Active strength
- 2.9; 4.9; 7.6 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 2.9 g/100mL |
| OCTISALATE | 4.9 g/100mL |
| OCTOCRYLENE | 7.6 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80641-013-01 | Drops | 1 in 1 KIT | LIQUID | 1 | | 4 |
| 80641-013-80 | Drops | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 4 |
| 80641-013-94 | Drops | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80641-013 | DROPS (AVOBENZONE OCTISALATE OCTOCRYLENE) LIQUID [VACATION INC.] | 4 | Current NDC, 3 package rows | 20250223_1319d6ea-a580-79c5-e063-6394a90a4dca.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80641-013-01 | 80641001301 | 1 BOTTLE, DROPPER in 1 KIT (80641-013-01) / 30 mL in 1 BOTTLE, DROPPER (80641-013-94) | | 2024-03-07 | No | No | Current |
| 80641-013-80 | 80641001380 | 30 mL in 1 BOTTLE, DROPPER (80641-013-80) | 30 ml | 2024-03-07 | No | No | Current |
| 80641-013-94 | 80641001394 | 30 mL in 1 BOTTLE, DROPPER | 30 ml | | | | Historical |