Label: LBEL- octinoxate and oxybenzone powder
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-240-01, 14783-240-02 - Packager: Ventura International Ltd. (San Francisco, CA)
- 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 May 16, 2011
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Other Information
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Inactive ingredients
isostearyl neopentanoate, mica, c12-15 alkyl benzoate, ethylhexyl palmitate, polymethyl methacrylate, dimethicone/vinyl dimethicone crosspolymer, polyethylene, ozokerite, kaolin, copernicia cerifera cera (copernicia cerifera (carnauba) wax), zea mays starch (zea mays (corn) starch), kojic dipalmitate, phenoxyethanol, dimethicone, octyldodecanol, glyceryl isostearate, isostearyl alcohol, methylparaben, silica, butyrospermum parkii (butyrospermum parkii (shea butter)), cera microcristallina (microcrystalline wax), propylparaben, beta-sitosterol, parfum (fragrance), candelilla cera (euphorbia cerifera (candelilla) wax), trimethylsiloxysilicate, petrolatum, phospholipids, bht, glycyrrhiza glabra root extract (glycyrrhiza glabra (licorice) root extract), butylparaben, ethylparaben, cholesterol, isobutylparaben, cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, chitosan, glycosphingolipids. May contain: ci 77891 (titanium dioxide), ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).
- PRINCIPAL DISPLAY PANEL - 8 g Carton
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT
octinoxate and oxybenzone powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-240 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) CERESIN (UNII: Q1LS2UJO3A) KAOLIN (UNII: 24H4NWX5CO) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) KOJIC DIPALMITATE (UNII: 13N249RWTM) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) OCTYLDODECANOL (UNII: 461N1O614Y) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) METHYLPARABEN (UNII: A2I8C7HI9T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SHEA BUTTER (UNII: K49155WL9Y) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) .BETA.-SITOSTEROL (UNII: S347WMO6M4) CANDELILLA WAX (UNII: WL0328HX19) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) YELLOW WAX (UNII: 2ZA36H0S2V) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-240-02 1 in 1 BOX 1 NDC:14783-240-01 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 08/16/2010 Labeler - Ventura International Ltd. (San Francisco, CA) (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE