| Product NDC: | 14783-094 |
| Proprietary Name: | LBEL UV DEFENSE 365 |
| Non Proprietary Name: | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| Active Ingredient(s): | .05; .07; .05; .04; .0624; .0388 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL & nbsp; Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | LOTION/SHAMPOO |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 14783-094 |
| Labeler Name: | Ventura International Ltd. (San Juan, P.R) |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | part352 |
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Start Marketing Date: | 20110829 |
| Package NDC: | 14783-094-04 |
| Package Description: | 1 BOTTLE in 1 BOX (14783-094-04) > 3 mL in 1 BOTTLE (14783-094-03) |
| NDC Code | 14783-094-04 |
| Proprietary Name | LBEL UV DEFENSE 365 |
| Package Description | 1 BOTTLE in 1 BOX (14783-094-04) > 3 mL in 1 BOTTLE (14783-094-03) |
| Product NDC | 14783-094 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide |
| Dosage Form Name | LOTION/SHAMPOO |
| Route Name | TOPICAL |
| Start Marketing Date | 20110829 |
| Marketing Category Name | OTC MONOGRAPH NOT FINAL |
| Labeler Name | Ventura International Ltd. (San Juan, P.R) |
| Substance Name | HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE |
| Strength Number | .05; .07; .05; .04; .0624; .0388 |
| Strength Unit | g/mL; g/mL; g/mL; g/mL; g/mL; g/mL |
| Pharmaceutical Classes |