PROVENCE CALENDULA AQUA SUN is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Nature Republic Co., Ltd.. The primary component is Octinoxate; Octisalate; Homosalate.
| Product ID | 51346-283_c733994b-4e3f-4883-a1ea-9b128d44bf6e |
| NDC | 51346-283 |
| Product Type | Human Otc Drug |
| Proprietary Name | PROVENCE CALENDULA AQUA SUN |
| Generic Name | Octinoxate, Octisalate, Homosalate |
| Dosage Form | Gel |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2015-02-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Labeler Name | NATURE REPUBLIC CO., LTD. |
| Substance Name | OCTINOXATE; OCTISALATE; HOMOSALATE |
| Active Ingredient Strength | 3 mg/50mL; mg/50mL; mg/50mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2015-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-02-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 3.25 mg/50mL |
| SPL SET ID: | 8f4fc901-6e98-4dab-9aa5-3dd4c77ec24e |
| Manufacturer | |
| UNII | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 51346-283 | PROVENCE CALENDULA AQUA SUN | OCTINOXATE, OCTISALATE, HOMOSALATE |
| 51346-433 | PROVENCE CALENDULA AQUA SUN | Octinoxate, Octinoxate |
| 69081-002 | Gloves in a Bottle with SPF15 | Octinoxate, octisalate, homosalate |
| 44099-011 | skin MD | octinoxate, octisalate, homosalate |
| 44099-001 | skin MD Natural | octinoxate, octisalate, homosalate |