Label: NO7 PROTECT AND PERFECT FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 WHEAT- octinoxate 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.

  • Carton active ingredient section


    Active ingredients Octinoxate 5%

    Purpose sunscreen.

  • Uses

    Uses - helps prevent sunburn.
    if used with as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

  • 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

  • Ask a doctor

    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 Centre right away.

  • Directions

    Directions

    apply liberally 15 minutes bfore 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 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

  • Storage

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

  • Inactive ingredients

    Cyclopentasiloxane, Aqua (Water) Isononyl isononanoate, Glycerin, Silica, Pheny trimethicone, Mica, Dimethicone, Arachidyl propionate, Talc, Titanium dioxide, Disteardimonium hectorite, PEG/PPG-10/1 dimethicone, Alcohol denat., Tocopheryl acetate, Hexyl laurate, Polyglyceryl-4 isostearate, Propylene carbonate, Methylparaben, Ethylparaben, Retinyl palmitate, Ascorbyl glucoside, Lupinus albus seed extract, Carbomer, Dimethylmethoxychromanol, Tetasodium EDTA, Phyllanthus emblica fruit extract, Polysorbate 20, Potasium hyroxide, Ginkgo biloba leaf extract, BHT, Ethylhexylglycerin, Tocopherol, Palmitoyl oligopeptide, Palmitoyl Tetrapeptide-7. May contain CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides).

  • Description

    Renewed radiance.

    Gain the immediate appearance of complexion perfection with our light diffusing formula that evens out skin tone. Minimises the appearance of fine lines for younger looking skin. Our Pro-retinol complex containing Lipopeptides boosts and maintain elasticity. Our powerful antioxidant complex and SPF 15 help protect against the ageing effects of free radicals.

    For Best Results: Shake before use. Blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face.

    Do not store above 30 degrees C or 86 degrees F.

    Hypo-allergenic: Because all skin can have sensitive moments all our foundation products are hypo-allergenic so they are kind to even the most sensitive skin.

  • INFORMATION

    The Boots Company PLC

    Nottingham

    England

    NG3 3AA

    Dist by Boots Retail USA Inc Norwalk CT 06851 USA

    Made in France

    www.boots.com.

  • Bottle label

    No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15

    Younger looking skin

    Hypo-allergenic 30ml 1 US Fl Oz

    Active ingredients

    Octinoxate 5%.

  • Warnings

    Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately.

  • Description

    Smoothes and moisturises for younger looking skin and a flawless, radiant complexion.

    For Best Results: Shake before use. Blend on smoothly and evenly with your fingers or a sponge.

  • INFORMATION FOR PATIENTS

    The Boots Company PLC Nottingham England NG2 3AA

    Dist by Boots Retail USA InC Norwalk CT 06851 USA

    Made in France

    www.boots.com.

  • carton label

    carton label1carton label 1

  • INGREDIENTS AND APPEARANCE
    NO7 PROTECT AND PERFECT FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 WHEAT 
    octinoxate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61589-5316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON (UNII: Z4152N8IUI)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MICA (UNII: V8A1AW0880)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    PHYLLANTHUS EMBLICA FRUIT JUICE (UNII: K8SGU56WPQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61589-5316-11 in 1 CARTON
    130 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/29/2012
    Labeler - BCM Cosmetique SAS (275359578)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Cosmetique SAS275359578manufacture(61589-5316)