Label: NO7 PROTECT AND PERFECT INTENSE DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene 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 December 18, 2012

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

  • ACTIVE INGREDIENT

    Active Ingredients Avobenzone 3.0%, Octisalate 2%, Octocrylene 4%

    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, hats, 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, Dimethicone, Cetearryl glucoside, Aluminum starch octenylsuccinate, Tribehenin, Ammonium acryloyldimethyltaurate/VP copolymer, phenoxyethanol, Alcohol denta.,Butyrospermum parkii (shea) butter, Potassium cetyl phosphate, Cetearyl alcohol, Butylene glycol, Dimethiconol, Methylparaben, Parfum (fragrance), Xanthan gum,  Ethylparaben, Dipropylene glycol, Retinyl palmitate, Ascorby glucoside, Sodium hyaluronate, Medicago sativa (alfalfa) extract,  Tetrasodium EDTA, T-butyl alcohol, Lupinus albus seed extract, Carbomer,  Phyllanthus emblica fruit extract, Dimethylmethoxy chromanol, Polysorbate 20, Potassium hydroxide, Ginkgo biloba leaf extract, Ethylhexylglycerin, Simethicone, Tocopherol,  Palmitoyl oligopeptide,  Palmitoyl tetrapeptide-7

  • QUESTIONS

    USA: Questions? 1-866-75-BOOTS

  • DESCRIPTION


    Smooth deep lines and wrinkles and help delay new ones with this protecting and renewing daytime formula. Created to answer your skin's needs now and help it have a more youthful-looking future. It is the perfect partner to our Protect and Perfect Intense Serum, formulated to be used together to deliver even better results than the serum alone.

  • INFORMATION FOR PATIENTS



    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

  • DESCRIPTION

    For best results: After cleansing, simply smooth into your face and neck with your fingertips, avoiding your eyes.

    With our skin firming pro-retinol complex containing Lipopeptides and Alfalfa extract that works to help restore the skin's structure and maintain elasticity.

  • Jar

    Active ingredients: Avobenzone 3%, Octisalate 2.%, Octocrylene 4%

  • warning

    JAR TEXT

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

  • DESCRIPTION

    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. by Boots Retail USA Inc.

    Norwalk CT 06851 USA

    Made in the UK
    www.Boots.com

  • carton

    image description

  • INGREDIENTS AND APPEARANCE
    NO7 PROTECT AND PERFECT INTENSE DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.5 g  in 50 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2 g  in 50 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Alcohol (UNII: 3K9958V90M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Butylene glycol (UNII: 3XUS85K0RA)  
    methylparaben (UNII: A2I8C7HI9T)  
    Xanthan gum (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALFALFA (UNII: DJO934BRBD)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    ginkgo (UNII: 19FUJ2C58T)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    tocopherol (UNII: R0ZB2556P8)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-077-011 in 1 CARTON
    150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/18/2012
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-077) , analysis(11489-077)