Orange Gel
- Product NDC
- 80641-016
- 11-digit product format
- 806410016
- Labeler code
- 80641
- Product ID
- 80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone Octisalate Octocrylene Homosalate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Vacation Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-03-08
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 2.9; 6.9; 4.9; 9.5 g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orange Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 2.9 g/100g |
| HOMOSALATE | 6.9 g/100g |
| OCTISALATE | 4.9 g/100g |
| OCTOCRYLENE | 9.5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80641-016-02 | Orange Gel | 2 in 1 CARTON | GEL | 2 | | 4 |
| 80641-016-30 | Orange Gel | 88 g in 1 TUBE | GEL | 88 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80641-016 | ORANGE GEL (AVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATE) GEL [VACATION INC.] | 3 | Current NDC, 2 package rows | 20250420_132896ef-d6c6-4ec7-e063-6294a90a103b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80641-016-02 | 80641001602 | 2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30) | 2 tube | 2025-04-18 | No | No | Current |
| 80641-016-30 | 80641001630 | 88 g in 1 TUBE (80641-016-30) | 88 g | 2024-03-08 | No | No | Current |