I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN SUEDE- 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

Active Ingredients:

Zinc Oxide - 8.5 %

Titanium Dioxide - 9.8%

Purpose: Sunscreen

Uses:

Warning:

Do not use:

When using this products:

Stop use and ask a doctor

Keep out of reach of children:

Directions for Sunscreen use:

Inactive Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Coconut Alkanes, Squalne, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone, Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Tetradecane, Mica, Cyclohexasiloxane, Magnesium Sulfate, Polyhydroxystearic Acid, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perflurorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europa (Olive) Leaf Extract, Algae Extract, Phospholipids, Artemisia Vulgaris Extract, Hyaluronic Acid, Isomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl Palmitate, Tocopherol, Ascorbyl Palmitate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Phenoxyethanol, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pantearythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothionine, [+/-: Ci 77163, Ci 77492, Ci 77491, Ci 77499, Beta-carotene].

Manufactured for:

IMAGE Skincare, Lantana, FL 33462 USA

Manufactured in USA from globally

sourced ingredients and components

www.ImageSkincare.com

I Conceal SuedeSPF 30

I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN SUEDE 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE85 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE98 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
SQUALANE (UNII: GW89575KF9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
TETRADECANE (UNII: 03LY784Y58)  
MICA (UNII: V8A1AW0880)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
PERFLUNAFENE (UNII: 54A06VV62N)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
HYALURONIC ACID (UNII: S270N0TRQY)  
ISOMALT (UNII: S870P55O2W)  
CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
SORBIC ACID (UNII: X045WJ989B)  
WINE GRAPE (UNII: 3GOV20705G)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BETA CAROTENE (UNII: 01YAE03M7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4175-21 in 1 CARTON10/04/2019
1NDC:62742-4175-128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/04/2019
Labeler - Allure Labs Inc (926831603)

Revised: 10/2019
Document Id: e7e6b0be-5b57-4492-a272-266693f32adc
Set id: 0e481271-7272-4954-9b5c-a2eaf82e2a43
Version: 1
Effective Time: 20191004
 
Allure Labs Inc