NO FOUNDATION SPF 30  - zinc oxide and titanium dioxide cream 
Allure Labs, Inc.

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.

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Drug Facts


PURPOSE:

Sunscreen


USES:

WARNINGS:

WHEN USING THIS PRODUCT:

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

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


DIRECTIONS:

STORAGE:

OTHER INFORMATION:

INACTIVE INGREDIENTS:

Aqua (Water), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Tetrahexyldecyl Ascorbate, C12-15 Alkyl Benzoate, Dimethicone, Sorbitan Stearate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Cyclohexasiloxane, Iron Oxides (77499, 77491, 77492), Glycolic Acid, Dimethyl MEA (DMAE), Mica, Phenoxyethanol, Citric Acid, Tribehenin, Caprylyl Glycol, Lecithin, Cetyl Alcohol, Tocopheryl Linoleate/Oleate, Thioctic Acid (Alpha-Lipoic Acid), Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, PEG-8, Triethoxysilylethyl Polydimethylsilxyethyl Hexyl Dimethicone, Polyacrylamide, Citrus Medica Limonum (Lemon) Peel Oil, Limonene, Sodium Lactate, Ceramide-2, Aluminum Hydroxide, Stearic Acid, C13-14 Isoparaffin, PEG-10 Rapeseed Sterol, Disodium EDTA, Dipotassium Glycyrrhizate, Tocopherol, Phoenix Dactylifera (Date) Fruit Extract, Silica Dimethyl Silylate,  Teprenone, Triethoxycaprylylsilane, Linalool, Laureth-7, Silica, Ascorbyl Palmitate, Hyaluronic Acid, Ascorbic Acid, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Palmitoyl Oligopeptide, Salvia Sclarea (Clary) Extract, Cedrus Atlantica Bark Oil, Ilex Paraguariensis Leaf Extract, Bulnesia SarmientoiWood Oil, Coriandrm Sativum (Coriander) Fruit Oil, Salvia Sclarea (Clary) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Triticum Vulgare (Wheat) Bran Extract, Anthemis Nobilis Flower Oil, Jasminum Officinale (Jasmine) Oil, Viola Odorata Flower/Leaf Extract.

DISTRIBUTOR (US):

NV Perricone LLC,

Meriden CT 06450.

DISTRIBUTOR (UK):

NV Perricone MD Cosmeceuticals LTD

London, W1T 3LN UK

www.perriconemd.com

1 888 823 7837

IMAGE OF THE PRODUCT:

Image of Product: Perricone MD No Foundation SPF30

NO FOUNDATION SPF 30  
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE122 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
2-(DIETHYLAMINO)ETHANOL (UNII: S6DL4M053U)  
MICA (UNII: V8A1AW0880)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALPHA-TOCOPHEROL, D- (UNII: N9PR3490H9)  
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ACRYLAMIDE (UNII: 20R035KLCI)  
LEMON OIL (UNII: I9GRO824LL)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
DATE (UNII: H3O7QI5HY7)  
TEPRENONE (UNII: S8S8451A4O)  
LINALOOL, D- (UNII: F4VNO44C09)  
LAURETH-7 (UNII: Z95S6G8201)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
HYALURONIC ACID (UNII: S270N0TRQY)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CLARY SAGE (UNII: U3HSK5JC0Q)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
GUAIAC OIL (UNII: 81H0L6W02F)  
CORIANDER OIL (UNII: 7626GC95E5)  
CLOVE OIL (UNII: 578389D6D0)  
WHEAT BRAN (UNII: 6L966A1IMR)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
VIOLA ODORATA (UNII: AET12U8B74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4061-21 in 1 CARTON
1NDC:62742-4061-159 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/31/2013
Labeler - Allure Labs, Inc. (926831603)
Registrant - Allure Labs, Inc. (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs, Inc.926831603manufacture(62742-4061)

Revised: 12/2013
Document Id: 2e3befa1-ca89-42df-9933-d2403b24a6e3
Set id: 812fd181-abf9-4bba-9ce2-d542e47620d0
Version: 1
Effective Time: 20131231
 
Allure Labs, Inc.