Label: FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 HONEY- octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0827-1, 67938-0827-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 6, 2011
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- DESCRIPTION
- INDICATIONS AND USAGE
- WARNINGS
- OTC - ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 HONEY
octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0827 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.1988 mL in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) OLEIC ACID (UNII: 2UMI9U37CP) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 40 (UNII: STI11B5A2X) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) TROLAMINE (UNII: 9O3K93S3TK) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) KAOLIN (UNII: 24H4NWX5CO) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) SUCROSE LAURATE (UNII: 05Q7CD0E49) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) DOCOSANOL (UNII: 9G1OE216XY) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) Product Characteristics Color BROWN (Honey) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-0827-1 1 in 1 BOX 1 NDC:67938-0827-2 30 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/06/2011 Labeler - Elizabeth Arden, Inc (849222187)