LBEL UV DEFENSE 365 is a Topical Lotion/shampoo in the Human Otc Drug category. It is labeled and distributed by Ventura International Ltd. (san Juan, P.r). The primary component is Homosalate; Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide; Zinc Oxide.
| Product ID | 14783-094_56625705-f317-4a80-9167-edcfacaf5d93 |
| NDC | 14783-094 |
| Product Type | Human Otc Drug |
| Proprietary Name | LBEL UV DEFENSE 365 |
| Generic Name | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide |
| Dosage Form | Lotion/shampoo |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2011-08-29 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Labeler Name | Ventura International Ltd. (San Juan, P.R) |
| Substance Name | HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE |
| Active Ingredient Strength | 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2011-08-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-08-29 |
| Inactivation Date | 2019-10-29 |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-08-29 |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-08-29 |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-08-29 |
| Inactivation Date | 2019-10-29 |
| Marketing Category | OTC monograph not final |
| Application Number | part352 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-08-29 |
| Inactivation Date | 2019-10-29 |
| Ingredient | Strength |
|---|---|
| HOMOSALATE | .05 g/mL |
| SPL SET ID: | 1655bbef-303a-4719-9d28-22a3c7d641f6 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13537-402 | LBEL UV DEFENSE 365 | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| 14783-094 | LBEL UV DEFENSE 365 | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| 13537-177 | LBEL DEFENSE 365 oil-free daily protective facial SPF 50 | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| 14783-992 | LBEL DEFENSE 365 oil-free daily protective facial SPF 50 | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |