COOLA Classic Body Sunscreen Fragrance-Free
- Product NDC
- 54111-145
- 11-digit product format
- 541110145
- Labeler code
- 54111
- Product ID
- 54111-145_5368324e-9b83-48dc-8ab3-88146d9423f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bentley Laboratories, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-06
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 1.75; 5; 2; 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 Classic Body Sunscreen Fragrance-Free
- Brand name suffix
- SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVOBENZONE | 1.75 g/100mL |
| HOMOSALATE | 5 g/100mL |
| OCTISALATE | 2 g/100mL |
| OCTOCRYLENE | 5 g/100mL |
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 |
|---|
| 54111-145-51 | COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 | 148 mL in 1 TUBE | LOTION | 148 | | 6 |
| 54111-145-51 | COOLA Classic Body Sunscreen Fragrance-FreeSPF 50 | 1 in 1 BOX | LOTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54111-145 | COOLA CLASSIC BODY SUNSCREEN FRAGRANCE-FREE SPF 50 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20231221_57f2fdeb-2abc-4ad3-bb89-5faee883c0e5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54111-145-51 | 54111014551 | 1 TUBE in 1 BOX (54111-145-51) / 148 mL in 1 TUBE | 1 tube | 2019-11-06 | 2023-12-31 | No | No | Current |