Label: ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50- ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-224-01 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated December 17, 2013
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- ACTIVE INGREDIENT
- Uses
- Warnings
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- Other information
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Inactive ingredients
Aqua (water), arginine, butylparaben, ceteareth-20, cetearyl alcohol, cyclohexasiloxane, cyclopentasiloxane, dicaprylyl carbonate, dimethicone, disodium lauriminodipropionate tocopheryl phosphates, ethylparaben, glyceryl stearate, isobutylparaben, methicone, methyl methacrylate crosspolymer, methylparaben, parfum (fragrance), phenethyl benzoate, phenoxyethanol, potassium cetyl phosphate, propylparaben, silica, sorbitan stearate, trimethylsiloxysilicate, vp/eicosene copolymer, xanthan gum.
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INGREDIENTS AND APPEARANCE
ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50
ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole 0.03 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.07 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.06 g in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.046 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARGININE (UNII: 94ZLA3W45F) BUTYLPARABEN (UNII: 3QPI1U3FV8) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M) ETHYLPARABEN (UNII: 14255EXE39) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) METHYLPARABEN (UNII: A2I8C7HI9T) PHENETHYL BENZOATE (UNII: 0C143929GK) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-224-01 80 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-224)