LBEL- ensulizole, octinoxate, and oxybenzone cream
LBel by
Drug Labeling and Warnings
LBel by is a Otc medication manufactured, distributed, or labeled by VENTURA INTERNATIONAL LTD.,. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aqua (water), c12-15 alkyl benzoate, cyclopentasiloxane, saccharomyces/xylinum/black tea ferment, triethanolamine, glycerin, cyclohexasiloxane, cetyl alcohol, glyceryl stearate, cetearyl alcohol, talc, propyleneglycol, peg-100 stearate, parfum (fragance), diazolidinyl urea, phenyl trimethicone, sodium lactate, acrylates/c10-30 alkylacrilate crosspolymer, ceteareth-20, hydroxyethylcellulose, methylparaben, propylparaben, butylene glycol, hydrolyzed keratin, arctostaphylos uva ursi/leaf extract, panthenol, citrus unshiu peel extract, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, ci 77891 (titanium dioxide), tetrasodium edta, dimethiconol, phenoxyethanol, nymphaea coerulea flower extract, ci 19140 (yellow 5), ci 14700 (red 4), butylparaben, ethylparaben, isobutylparaben.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ml Carton
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INGREDIENTS AND APPEARANCE
LBEL SUPREMACIE MAINS
ensulizole, octinoxate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 14783-072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 3 g in 100 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 6.2 g in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) c12-15 alkyl benzoate (UNII: A9EJ3J61HQ) cyclomethicone 5 (UNII: 0THT5PCI0R) tea leaf (UNII: GH42T47V24) trolamine (UNII: 9O3K93S3TK) glycerin (UNII: PDC6A3C0OX) cyclomethicone 6 (UNII: XHK3U310BA) cetyl alcohol (UNII: 936JST6JCN) glyceryl monostearate (UNII: 230OU9XXE4) cetostearyl alcohol (UNII: 2DMT128M1S) talc (UNII: 7SEV7J4R1U) propylene glycol (UNII: 6DC9Q167V3) polyoxyl 100 stearate (UNII: YD01N1999R) diazolidinyl urea (UNII: H5RIZ3MPW4) phenyl trimethicone (UNII: DR0K5NOJ4R) sodium lactate (UNII: TU7HW0W0QT) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) butylene glycol (UNII: 3XUS85K0RA) arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36) panthenol (UNII: WV9CM0O67Z) tangerine (UNII: KH3E3096OO) dimethicone (UNII: 92RU3N3Y1O) titanium dioxide (UNII: 15FIX9V2JP) edetate sodium (UNII: MP1J8420LU) phenoxyethanol (UNII: HIE492ZZ3T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) isobutylparaben (UNII: 0QQJ25X58G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14783-072-61 1 in 1 BOX 1 NDC: 14783-072-62 100 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2010 LBEL SUPREMACIE MAINS
ensulizole, octinoxate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 14783-062 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 0.15 g in 5 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.38 g in 5 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.31 g in 5 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) c12-15 alkyl benzoate (UNII: A9EJ3J61HQ) cyclomethicone 5 (UNII: 0THT5PCI0R) tea leaf (UNII: GH42T47V24) trolamine (UNII: 9O3K93S3TK) glycerin (UNII: PDC6A3C0OX) cyclomethicone 6 (UNII: XHK3U310BA) cetyl alcohol (UNII: 936JST6JCN) glyceryl monostearate (UNII: 230OU9XXE4) cetostearyl alcohol (UNII: 2DMT128M1S) talc (UNII: 7SEV7J4R1U) propylene glycol (UNII: 6DC9Q167V3) polyoxyl 100 stearate (UNII: YD01N1999R) diazolidinyl urea (UNII: H5RIZ3MPW4) phenyl trimethicone (UNII: DR0K5NOJ4R) sodium lactate (UNII: TU7HW0W0QT) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) butylene glycol (UNII: 3XUS85K0RA) arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36) panthenol (UNII: WV9CM0O67Z) tangerine (UNII: KH3E3096OO) dimethicone (UNII: 92RU3N3Y1O) titanium dioxide (UNII: 15FIX9V2JP) edetate sodium (UNII: MP1J8420LU) phenoxyethanol (UNII: HIE492ZZ3T) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) isobutylparaben (UNII: 0QQJ25X58G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14783-062-51 1 in 1 BOX 1 NDC: 14783-062-52 5 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2010 Labeler - VENTURA INTERNATIONAL LTD., (603192787)
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