PERRICONE NO FOUNDATION FOUNDATION- zinc oxide, titanium dioxide cream

Perricone by

Drug Labeling and Warnings

Perricone by is a Otc medication manufactured, distributed, or labeled by NV Perricone LLC, Cofran International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                             Purpose

Zinc Oxide 12.2%                          Sunscreen

Titanium Dioxide  3.2%                  Sunscreen

Uses

Helps Prevent sunburn

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

stop use and ask a doctor if

rash occurs

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

Perricone MD Cosmeceuticals

No Foundation Foundation

Broad Spectrum SPF 30 sunscreen

30 mL/1 fl oz

INGREDIENTS AND APPEARANCE

PERRICONE  NO FOUNDATION FOUNDATION
zinc oxide, titanium dioxide cream

Product 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