Label: LBEL EFFET PARFAIT- titanium dioxide, oxybenzone, and octinoxate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-148-01, 13537-148-02, 13537-148-03, 13537-148-04 - Packager: Ventura Corporation Ltd
- 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 January 25, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Inactive ingredients
Talc, Mica, Boron Nitride, Alumina, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Kaolin, Glyceryl Caprylate, Isononyl Isononanoate, Glycerin, Lycopodium Clavatum Exine, Hydrogen Dimethicone, Lauroyl Lysine, Fragrance, Ceramide 3, Methylparaben, Propylparaben, Imperata Cylindrica Root Extract. May Contain: CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 g Compact Carton
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT
titanium dioxide, oxybenzone, and octinoxate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-148 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.04425 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.03 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.04 g in 1 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) BORON NITRIDE (UNII: 2U4T60A6YD) ALUMINUM OXIDE (UNII: LMI26O6933) KAOLIN (UNII: 24H4NWX5CO) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) LAUROYL LYSINE (UNII: 113171Q70B) CERAMIDE 3 (UNII: 4370DF050B) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-148-02 1 in 1 BOX 1 NDC:13537-148-01 10 g in 1 CASE 2 NDC:13537-148-04 1 in 1 BOX 2 NDC:13537-148-03 7.8 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/24/2012 Labeler - Ventura Corporation Ltd (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-148)
