Label: NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate cream

  • 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 June 1, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredients Avobenzone (3.0%), Octinoxate (6.0%), Octisalate (2.5%)

    Purpose Sunscreen

  • PURPOSE

    Uses helps prevent sunburn

  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only

    Do not use on damaged or broken skin

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


  • ASK 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 control center right away.

  • INDICATIONS & USAGE

    Directons

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Chidren 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 10a,m - 2p.m

    wear long-sleeved shirts, pants, hat and sunglasses


  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua (water), Glycerin, C12-15 alkyl benzoate, Butyrospermum parkii (shea) butter, Dimethicone, Isononyl isonanoate, Cetearyl alcohol, C18-36 acid glycol ester, Polyglyceryl-3-methylglucose distearate, Phenoxyethanol, Polyacrylamide, Sorbitan stearate, Mica, Polysorbate 20, Alcohol denat., Methylparaben, Potassium cetyl phosphate, Ethylparaben, Parfum (fragrance), Laureth-7, Retinyl palmitate, Sucrose cocoate, Dipropylene glycol, Xanthan gum, ascorbyl glucoside, Tetrasodium EDTA, Citric acid, Lupinus albus seed extract, Dimethylmethoxy chromanol, Carbomer, Phyllanthus emblica fruit extract, Potassium hydroxide, Ginkgo biloba leaf extract, BHT, Tocopherol, Butylparaben, Palmitoyl oligopeptide, Propylparaben, Isobutylparaben, Palmitoyl tetrapeptide-7, CI 77891 (Titanium dioxide)

  • QUESTIONS

    USA: Questions? 1-866-75-BOOTS

  • DESCRIPTION


    Smooth fine lines and help delay new ones with this protecting  and revitalising daytime formula, your first defence against the early signs of ageing. Created to be used with our protect and pefect serum to help deliver even better results that the serum alone.

  • INFORMATION FOR PATIENTS

    Hypoallergenic

    The Boots company PLC Nottingham England NG2 3AA

    Dist. by Boots Retail USA Inc. Norwalk CT 06851 USA

    Made in the UK
    www.Boots.com/no7

  • DESCRIPTION

    For best results use every morning after cleansing and applying protect and perfect serum. Simply smooth into our face and neck with your fingertips, avoiding your eyes.

    With our firming pro-retinol complex containing lipopeptides to help boost and maintain elasticity.

  • ACTIVE INGREDIENT

    JAR TEXT

    Active ingredients: Octinoxate 6%, Avobenzone 3%, Octisalate 2.5%

  • WARNINGS

    JAR TEXT

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

  • INDICATIONS & USAGE

    JAR TEXT

    Smooth into your face and neck after applying your No7 serum.

  • INFORMATION FOR PATIENTS

    JAR TEXT


    The Boots Company PLC Nottingham England NG2 3AA

    Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA

    Made in the UK
    www.Boots.com/no7

  • PRINCIPAL DISPLAY PANEL

    No7 Protect and Perfect

    Day Cream

    Protects young skin to delay the appearance of fine lines

    Sunscreen broad spectrum SPF 15

    50ml 1.6US Fl.Oz

    P and P Day Cream carton.jpgP and P Day Cream carton

  • PRINCIPAL DISPLAY PANEL

    JAR TEXT

    No7 Protect and Perfect Day Cream

    Hypo-allergenic

    Sunscreen Broad Spectrum SPF 15

    50ml 1.6 US Fl.Oz

    P and P Day Cream jar.jpgP and P Day Cream jar

  • INGREDIENTS AND APPEARANCE
    NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.5 mL  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3 mL  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.25 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    mica (UNII: V8A1AW0880)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    LAURETH-7 (UNII: Z95S6G8201)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GINKGO (UNII: 19FUJ2C58T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68472-109-011 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2012
    Labeler - Boots Retail USA Inc (143151533)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis