Label: NO FOUNDATION FOUNDATION NO.1 FAIR TO LIGHT- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4063-1, 62742-4063-2 - Packager: Allure Labs, 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 April 18, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions:
- Dr. Perricone recommends applying evenly with your fingertips and blending product in circular motions. Can be re-applied as necessary to build desired coverage.
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Re apply at least every 2 hours.
- Not for use on children.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including;
1. Limit time in the sun, especially between 10am to 2pm - 2. Wear long sleeved shirts, pants, hats, and sun glasses
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Water/Aqua, Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Dimethicone, Sorbitan Stearate, Ethylhexyl Palmitate, Cyclohexasiloxane, Aluminum Hydroxide, Stearic Acid, C12-C15 Alkyl Benzoate, Triethoxysilyethyl Polydimethylsiloxyethy Hexyl Dimethicone, Mica, Dimethyl MEA, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Glycolic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499) Caprylyl Glycol, Cetyl Alcohol, Tocopheryl Linoleate/Oleate, Lecithin, Tribehenin, Citric Acid, Xanthan Gum, Ethylhexylglycerin, Hexylele Glycol, PEG-8, Fragrance/Parfum, Polyacrylamide, Sodium Lactate, C13-14 Isoparaffin, Disodium EDTA, Diopotassium Glycyrrhizate, Tocopheryl, Ceramide 2, Pheonix Dactylifera (Date) Fruit Extract, PEG-10 Rapeseed Sterikm Silica Dimethyl Silylate, Laureth-7, Thiotic Acid, Silica, Ascorbyl Palmitate, Limonene, Linalool, Triethoxycaprylylsilane, Ascorbic Acid, Sodium Hyaluronate, Palmitoyl Oligopeptide
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NO FOUNDATION FOUNDATION NO.1 FAIR TO LIGHT
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 122 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ETHYLHEXYL PALMITATE (UNII: 2865993309) CYCLOMETHICONE 6 (UNII: XHK3U310BA) Aluminum Hydroxide (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ) MICA (UNII: V8A1AW0880) DEANOL (UNII: 2N6K9DRA24) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCOLIC ACID (UNII: 0WT12SX38S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Caprylyl Glycol (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) TRIBEHENIN (UNII: 8OC9U7TQZ0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) SODIUM LACTATE (UNII: TU7HW0W0QT) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE 2 (UNII: C04977SRJ5) DATE (UNII: H3O7QI5HY7) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAURETH-7 (UNII: Z95S6G8201) .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) ASCORBYL PALMITATE (UNII: QN83US2B0N) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4063-2 1 in 1 CARTON 1 NDC:62742-4063-1 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 04/18/2014 Labeler - Allure Labs, Inc (926831603)