NDC | 20146-4008-1, 20146-4008-2 |
Set ID | ce3a5ddc-9d4d-4d63-879c-fc4aef9a0a0a |
Category | HUMAN OTC DRUG LABEL |
Packager | SAMSON PHARMACEUTICAL |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
- Directions
- Other information
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Inactive Ingredients
Water (Aqua), Stearyl Alcohol, Cetyl Alcohol, Ethylhexyl Palmitate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Mineral Oil, PVP, Aloe Barbadensis Leaf Juice, Menthone Glycerin Acetal, Triethanolamine, Carbomer, Tetrasodium EDTA, Phenoxyethanol, Ethylhexyl Glycerin, PEg-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Buthylphenyl Methylpropional, Alpha-Isomethyl Ionone, Hydroxyisohexyl 3-Clyclohexene Carboxaldehyde, Coumarin, Linalool
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28 g Tube Label
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INGREDIENTS AND APPEARANCE
LA BODIES ECLIPSE SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20146-4008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 g Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 150 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 24 mg in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 mg in 1 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) stearyl alcohol (UNII: 2KR89I4H1Y) cetyl alcohol (UNII: 936JST6JCN) glyceryl monostearate (UNII: 230OU9XXE4) PEG-100 stearate (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20146-4008-1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:20146-4008-2 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/01/2015 Labeler - SAMSON PHARMACEUTICAL (088169581) Establishment Name Address ID/FEI Business Operations SAMSON PHARMACEUTICAL 088169581 MANUFACTURE(20146-4008)