Label: MDSOLARSCIENCES SPF40 ULTRA-SPORT- meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 17452-360-01 - Packager: Ecometics, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 15, 2010
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Inactive Ingredients
Caprlyl Methicone, Cyclopentasiloxane, Butyrospemum Parkll (Shea Butter), Petrolatum, Beesewax, Polyethylene, C12-15 Alkyl Benzoate, Paraffin Wax, Simmondsia Chinensis (Jojoba) Butter, Copernicia Cerifera (Carnauba) Wax, Polyester-8, Hydrogenated Soybean Oil, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethysiloxyethyl Hexyl Dimethicone, Microcrystalline Wax, BHT, Aluminum Hydroxide, Tetrahexyldecyl Ascorbate
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INGREDIENTS AND APPEARANCE
MDSOLARSCIENCES SPF40 ULTRA-SPORT
meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17452-360 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ) Meradimate 0.35 g in 10 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.35 g in 10 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 1 g in 10 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.135 g in 10 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 1.025 g in 10 g Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) JOJOBA OIL (UNII: 724GKU717M) Carnauba Wax (UNII: R12CBM0EIZ) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17452-360-01 10 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2010 Labeler - Ecometics, Inc (064843923) Registrant - Ecometics, Inc (064843923) Establishment Name Address ID/FEI Business Operations Ecometics, Inc 064843923 manufacture