Label: LYCOGEL COVER AND RECOVERY - BREATHABLE CAMOUFLAGE - SPF 30 WITH LYCO COMPLEX- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated February 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: 6.5% TITANIUM DIOXIDE

                                        8.2% ZINC OXIDE

  • INACTIVE INGREDIENT

    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 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)
  • PRINCIPAL DISPLAY PANEL


    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

    -------------------------------------------

    Active Ingredients:

    Inactive Ingredients:

    (as listed above)

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

    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.

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

    6. Bottom: Shade name sticker (Almond, Caramel, Creme, Honey, Green, Pink, Beige, Taupe, Cocoa, Ebony, Ivory, Tawny, Oaker, and Yellow)

    IMAGE OF PRINICPAL PANEL DISPLAY

  • INGREDIENTS AND APPEARANCE
    LYCOGEL COVER AND RECOVERY - BREATHABLE CAMOUFLAGE - SPF 30 WITH LYCO COMPLEX 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4031
    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:62742-4031-21 in 1 CARTON
    1NDC:62742-4031-120 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