LYCOGEL COVER AND RECOVERY - BREATHABLE CONCEALER - SPF 30 WITH LYCO COMPLEX - titanium dioxide and zinc oxide cream 
Allure Cosmetic, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active Ingredients: 6.5% TITANIUM DIOXIDE

                                    8.2% ZINC OXIDE

Inactive Ingredients:
WATER, CYCLOPENTASILOXANE, DIMETHICONE, PEG-10/15 CROSSPOLYMER, CYCLOMETHICONE, SACCHAROMYCES LYSATE EXTRACT, HYDRATED SILICA, PEG/PPG-18/18 DIMETHICONE, MALUS DOMESTICA FRUIT CELL CULTURE, CYPERUS ROTUNDUS ROOT EXTRACT, LONICERA JAPONICA FLOWER EXTRACT, XANTHIUM SIBIRICUM FRUIT EXTRACT, SODIUM HYALURONATE, SQUALANE (OLIVE), ACETYL TETRAPEPTIDE-15, PHOSPHOLIPIDS, RETINYL PALMITATE, TOCOPHEROL ACETATE, ASCORBYL PALMITATE, BETA-CAROTENE, SANTALUM ALBUM (SANDALWOOD) EXTRACT, PHELLODENDRON AMURENSE BARK EXTRACT, HORDEUM DISTICHON (BARLEY) EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, ALGAE EXTRACT, ARTEMISIA VULGARIS EXTRACT, ZINC PCA, CENTELLA ASIATICA EXTRACT, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES ETHYLHEXYL ACRYLATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL  HEXYL DIMETHICONE, XANTHAN GUM, GLYCERIN, LECITHIN, MANNITOL, SODIUM CITRATE, ALUMINUM HYDROXIDE, STEARIC ACID, PHENOXYETHANOL, ISOHEXADECANE, CAPRYLYL GLYCOL, ETHYLHEXYLGYCERINE, HEXYLENE GLYCOL, SODIUM BENZOATE.
MAY CONTAIN: Cl 77491, Cl 77492, Cl 77499 (IRON OXIDE), Cl 77891 (TITANIUM DIOXIDE)


Information on Carton Label:

1. Principal Display Panel: Shown in the image below.

2. Back Panel:

Manufactured for and distributed by

Quura Medical, BV. 1272 CB, The Netherlands

www.lycogel.eu

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Active Ingredients:

Inactive Ingredients:

(as listed above)

3. Side Panel A: Lycogel Cover and Recovery

4. Side Panel B: Use Benefits

The first breathable colour corrective treatment that combines cosmetic and skincare technology to promote post procedure healing, soothe sensitive skin, rejuvenate and camouflage at the same time.

Lycogel's  revolutionary technology combines a unique breathable Tripple Silica Gel Base with LYCO Complex, a carefully balanced set of bio-active agents that work synergistically to improve the skin.

Directions: Dispense a small amount and apply with clean sponge or fingertips. Apply in buildable layers for more coverage using a patting technique.

Warning: For external use only. Avoid contact with eyes. Discontinue use if irritation occurs and consult your skin specialist.

5.Top: Cover and Recovery printed in white on gray background.

6. Bottom: Shade name sticker (Green, Pink, Oaker, and Yellow)

IMAGE OF PRINICPAL PANEL DISPLAY

LYCOGEL COVER AND RECOVERY - BREATHABLE CONCEALER - SPF 30 WITH LYCO COMPLEX 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE65 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE82 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
APPLE (UNII: B423VGH5S9)  
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
XANTHIUM (UNII: 8555ORT735)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SQUALANE (UNII: GW89575KF9)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
BETA CAROTENE (UNII: 01YAE03M7J)  
PHELLODENDRON AMURENSE (UNII: PBG27B754G)  
BARLEY (UNII: 5PWM7YLI7R)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4032-21 in 1 CARTON
1NDC:62742-4032-16 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2010
Labeler - Allure Cosmetic, Inc. (926831603)
Registrant - Allure Cosmetic, Inc. (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Cosmetic, Inc.926831603manufacture

Revised: 2/2010
Document Id: 6cd649e2-95e4-4138-b16d-9e95e2f328b8
Set id: b66b24bb-3961-45ed-88d2-4e81c2ff7ff7
Version: 1
Effective Time: 20100208
 
Allure Cosmetic, Inc.