Label: LBEL- titanium dioxide, oxybenzone, zinc oxide, and octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-013-10, 14783-013-11 - Packager: Ventura International, Limited
- 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 November 10, 2010
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- ACTIVE INGREDIENT
- Uses
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- Other information
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Inactive ingredients
Mica, Boron Nitride, Zea Mays Starch( zea mays (corn) starch), Zinc Stearate, Silica, Isononyl Isononanoate, Magnesium Myristate, Simmondsia Chinensis seed oil(simmondsia chinensis (jojoba) seed oil), Glyceryl Caprylate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Tocopheryl Acetate, Triethoxycaprylylsilane, Rhodiola Rosea Root Extract, Carnosine, Alanyl Glutamine. May contain: Iron Oxides, Titanium Dioxide.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 g Container Carton
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT MINERAL
titanium dioxide, oxybenzone, zinc oxide, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.06 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.05 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.049 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.035 g in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) STARCH, CORN (UNII: O8232NY3SJ) ZINC STEARATE (UNII: H92E6QA4FV) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) JOJOBA OIL (UNII: 724GKU717M) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) CARNOSINE (UNII: 8HO6PVN24W) ALANYL-GLUTAMINE (UNII: U5JDO2770Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-013-11 1 in 1 CARTON 1 NDC:14783-013-10 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 12/15/2010 Labeler - Ventura International, Limited (603192787) Establishment Name Address ID/FEI Business Operations BelStar, S.A. 880160197 MANUFACTURE