Label: I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY- zinc oxide and titanium dioxide cream

  • NDC Code(s): 62742-4214-1, 62742-4214-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 18, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

    Titanium Dioxide 6.5%

    Zinc Oxide 8.5%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburn.

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    On damaged or broken skin.

  • WHEN USING

    When using this product

    Keep out of eyes. Rinse with water to remove

  • STOP USE

    Stop use and ask a doctor if • Rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions For Sunscreen Use • Apply generously 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: • immediately after towel drying. • at least every 2 hours.

  • OTHER SAFETY INFORMATION

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses.

    Other information • Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water/Aqua/Eau, Coconut Alkanes, Cyclopentasiloxane, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, lsohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxystearic Acid, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ettylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perfluorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europaea (Olive) Leaf Extract, Artemisia Vulgads Extract, Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, lsomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl PaImitate, Ascorbyl Palmitate, Tocopheryl Acetate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Tocopherol, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothioneine, Iron Oxides (CI 77492), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

  • PRINCIPAL DISPLAY PANEL

    I Conceal Mahogany

  • INGREDIENTS AND APPEARANCE
    I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4214
    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 DIOXIDE65 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PERFLUNAFENE (UNII: 54A06VV62N)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    SORBIC ACID (UNII: X045WJ989B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ISOMALT (UNII: S870P55O2W)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICA (UNII: V8A1AW0880)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SQUALANE (UNII: GW89575KF9)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4214-21 in 1 CARTON04/18/2022
    1NDC:62742-4214-128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/18/2022
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4214)