COOLA Refreshing Water Mist SPF 18
- Product NDC
- 54111-148
- 11-digit product format
- 541110148
- Labeler code
- 54111
- Product ID
- 54111-148_aae99fc7-d6b1-44fc-a2d8-0004df757b85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Bentley Laboratories, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-07-30
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 2; 10; 5; 5.5 g/100mL; 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
- COOLA Refreshing Water Mist SPF 18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 2 g/100mL |
| HOMOSALATE | 10 g/100mL |
| OCTISALATE | 5 g/100mL |
| OCTOCRYLENE | 5.5 g/100mL |
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 |
|---|
| 54111-148-50 | COOLA Refreshing Water Mist SPF 18 | 1 in 1 CARTON | SPRAY | 1 | | 3 |
| 54111-148-50 | COOLA Refreshing Water Mist SPF 18 | 50 mL in 1 BOTTLE | SPRAY | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54111-148 | COOLA REFRESHING WATER MIST SPF 18 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [BENTLEY LABORATORIES, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231220_658bf3fe-2246-40b6-8cb1-969bfdaffd1b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54111-148-50 | 54111014850 | 1 BOTTLE in 1 CARTON (54111-148-50) / 50 mL in 1 BOTTLE | 1 bottle | 2020-07-30 | 2023-12-31 | No | No | Current |