Label: PERRICONE NO FOUNDATION FOUNDATION- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 45634-121-01, 45634-121-02 - Packager: NV Perricone LLC
- 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 April 24, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient Purpose
Zinc Oxide 12.2% Sunscreen
Titanium Dioxide 3.2% Sunscreen
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.
Warnings
For external use only
Do not use on damaged or broken skin
When using this product
Keep out of eyes. Rinse with water to remove
Directions
Dr. Perricone recommends applying evenly in gentle circular motions on top of treatment and or moisturizer. Can be re-applied as neccesary. Compatible with all Perricone MD products
Apply generously and evenly 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Not for use on children.
Aluminum Hydroxide, Anthemis Nobilis Flower Oil, Arabidopsis Thaliana Extract, Ascorbic Acid, Ascorbyl Palmitate, Bulnesia Sarmientoi Wood Oil, Butlylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cedrus Atlantica Bark Oil, Ceramide 2, Cetyl Alcohol, Citric Acid, Citrus Medica Limonium (Lemon) Peel Oil, Coriandrum Sativum (Coriander) Fruit Oil, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethyl MEA, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexylglycerin, Eugenia Caryophyllus (Clove) Flower Oil, Fragrance, Glycerin, Glyceryl Stearate, Glycolic acid, Hexylene Glycol, Hyaluronic Acid, Ilex Paraguariensis Leaf Extract, Iron Oxides (CI 77491, CI 77492, CI 77499). Jasminum Officinale (Jasmine) Oil, Laureth-7, Lecithin, Limonene, Linalool, Mica, Microccocus Lysate, Palmitoyl Oligopeptide, PEG-10 Rapeseed oil, PEG-100 Stearate, PEG-8, Phenoxyethanol, Phoenix Dactylifera (Date) Fruit Extract, Plankton Extract, Polyacrylamide, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Salvia Sclarea (Clary) Extract, Salvia Sclarea (Clary) Oil, Silica, Dimethyl Silylate, Sodium Lactate, Sorbitan Stearate, Stearic Acid, Teprenone, Tetrahexyldecyl Ascorbate, Thioctic Acid, Tocopheryl Linoleate/Oleate, Tribehenin, Triethoxycaprylylsilane, Triethoxysilyethyl Polymethylsiloxyethyl Hexyl Dimethicone, Triticum Vulgare (Wheat) Bran Extract, Viola Odorata Flower/Leaf Extract, Water, Xanthan Gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERRICONE NO FOUNDATION FOUNDATION
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45634-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.2 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) BULNESIA SARMIENTOI WOOD OIL (UNII: 81H0L6W02F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) CERAMIDE 2 (UNII: C04977SRJ5) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LEMON OIL (UNII: I9GRO824LL) CORIANDER OIL (UNII: 7626GC95E5) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) DEANOL (UNII: 2N6K9DRA24) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CLOVE OIL (UNII: 578389D6D0) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCOLIC ACID (UNII: 0WT12SX38S) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYALURONIC ACID (UNII: S270N0TRQY) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) LAURETH-7 (UNII: Z95S6G8201) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) LIMONENE, (+/-)- (UNII: 9MC3I34447) LINALOOL, (+/-)- (UNII: D81QY6I88E) MICA (UNII: V8A1AW0880) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) PEG-100 STEARATE (UNII: YD01N1999R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) DATE (UNII: H3O7QI5HY7) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) CLARY SAGE (UNII: U3HSK5JC0Q) CLARY SAGE OIL (UNII: 87L0D4U3M0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SODIUM LACTATE (UNII: TU7HW0W0QT) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARIC ACID (UNII: 4ELV7Z65AP) TEPRENONE (UNII: S8S8451A4O) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) TOCOPHEROL (UNII: R0ZB2556P8) TRIBEHENIN (UNII: 8OC9U7TQZ0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WHEAT BRAN (UNII: 6L966A1IMR) VIOLA ODORATA FLOWERING TOP (UNII: 04BPC87I4H) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45634-121-02 1 in 1 CARTON 1 NDC:45634-121-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/11/2012 Labeler - NV Perricone LLC (054414243) Registrant - Cofran International (122716855) Establishment Name Address ID/FEI Business Operations Cofran International 122716855 manufacture
