COOLA Classic Body Sunscreen Fragrance-Free SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Gordon Laboratories, Inc.. The primary component is Avobenzone; Octisalate; Octocrylene; Homosalate.
| Product ID | 21839-430_99db1eb6-9887-0781-e053-2a95a90a5e8f |
| NDC | 21839-430 |
| Product Type | Human Otc Drug |
| Proprietary Name | COOLA Classic Body Sunscreen Fragrance-Free SPF 50 |
| Generic Name | Avobenzone,homosalate, Octisalate,octocrylene |
| Dosage Form | Lotion |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Labeler Name | Gordon Laboratories, Inc. |
| Substance Name | AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE |
| Active Ingredient Strength | 18 mg/mL; mg/mL; mg/mL; mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-02-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | OTC monograph final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2019-02-28 |
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 17.5 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 54111-145 | COOLA Classic Body Sunscreen Fragrance-Free SPF 50 | COOLA Classic Body Sunscreen Fragrance-Free SPF 50 |
| 21839-430 | COOLA Classic Body Sunscreen Fragrance-Free | AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE |
| 21839-450 | COOLA Classic Body Sunscreen Guava Mango | AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE |
| 21839-620 | COOLA Full Spectrum 360 Sun Silk Drops | AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE |
| 21839-590 | COOLA Refreshing Water Mist Sunscreen | AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE |