Label: NO7 BEAUTIFULLY MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 DEEPLY BEIGE- octinoxate and titanium dioxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 30, 2012

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

  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If swallowed get medical help or contact a Poison control centre right away

  • ACTIVE INGREDIENT

    Drug Facts

    active ingredients octinoxate 5%

    Titanium Dioxide 1.6%

    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

  • INSTRUCTIONS FOR USE

    Directions

    apply liberally 15 minutes before sun exposure

    reapply at least every 2 hours

    use a water resistant sunscreen if swimming or sweating

    children under 6 months of age ask a doctor

    sun protectin 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 am to 2 pm, wear long sleeved shirts, pants, hats and sunglasses

  • STORAGE AND HANDLING

    protect the product in this container from excessive heat and direct sun

  • DESCRIPTION

    Soft natural matte foundation

    Specially created with our patented, fine, oil absorbing powder, this lightweight formulation glides on effortlessly to ensure shine breakthrough is controlled and your colour remains true all day. The unique mattifying formula ensures pores are less visble, whilst Salicylic acid helps fight against bacteria, which cause spots. Also contains our powerful anitoxidant complex and SPF 15 that will help protect against the ageing effects of the sun if the product is used as directed with other sun protection measures. For best results blend smoothly and evenly with your fingers or a sponge. Hypo-allergenic because all skin can have sensitive moments, all our foundation products are hypo-allergenic using ingredients we know and trust.

  • INACTIVE INGREDIENT

    inactive ingredients

    aqua (water), cyclopentasiloxane, phenyl trimethicone, alcohol denat, nylon 6/12, glycerin, cyclohexsiloxane, zinc oxide, disteardimonium hectorite, magnesium sulfate, PEG PPG 19/19 dimethicone, tocopheryl acetate, hexyl laurate, polyglyceryl-4- isostearate, propylene carbonate,lauryl methacrylate/glycol dimethacrylate cross polymer, salicylic acid, aluminum hydroxide, phenoxyethanol, lens esculenta fruit extract, stearic acid, triethoxycaprylylsilane, potassium hydroxide, retinyl palmitate, ascorbyl glucoside, tetrasodium edta, isopropyl palmitate, methylparaben, lecithin, ethylparaben, phyllanthus emblica fruit extract, dimethoxyl chromanol, ethylhexylglycerin, ginkgo biloba leaf extract, BHT, tocopherol, may contain CI 77891 (titanium dioxide).

  • INFORMATION FOR PATIENTS

    USA Questions?

    1-866-75-BOOTS

    The Boots Company PLC

    Nottingham England NG2 3AA

    Dist by Boots Retail USA Inc

    Norwalk CT 06851 USA

    Made in France

    www.Boots.Com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NO7 BEAUTIFULLY MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 DEEPLY BEIGE 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61589-6504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 30 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.48 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NYLON-12 (UNII: 446U8J075B)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61589-6504-11 in 1 CARTON
    130 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/26/2012
    Labeler - BCM Cosmetique SAS (275359578)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Cosmetique SAS275359578manufacture(61589-6504)