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

  • 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 October 4, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide - 8.5 %

    Titanium Dioxide - 9.8%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS AND PRECAUTIONS

    Warning:

    • For external use only.
  • DO NOT USE

    Do not use:

    • on damaged or broken skin.
  • WHEN USING

    When using this products:

    • Keep out of eyes. If contact occurs rinse with water to remove.
  • STOP USE

    Stop use and ask a doctor

    • if skin irritation develops. 
  • 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 exposer.
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease the 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 sleeve shirts, pants, hats and sunglasses.
  • INACTIVE INGREDIENT

    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].

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:

    IMAGE Skincare, Lantana, FL 33462 USA

    Manufactured in USA from globally

    sourced ingredients and components

    www.ImageSkincare.com

    I Conceal SuedeSPF 30

  • INGREDIENTS AND APPEARANCE
    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)