Label: NO7 BEAUTIFUL SKIN DAY CREAM NORMAL DRY 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 May 20, 2018

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  • Carton Active Ingredients Section

    Active ingredients

    Avobenzone 3%

    Octisalate 2%

    Octocrylene 4%

  • Uses

    Uses - helps prevent sunburn

  • 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 Control Center right away

  • Directions

    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 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

    Avoid contact with fabrics

  • Inactive ingredients

    Aqua(Water), Glycerin, C12-15 alkyl bezoate, Isostearyl isostearate, Dimethicone, Cetearyl glucoside, Aluminum starch octenylsuccinate, Tribehenin, Ammonium acryloydimethyltaurate/VP copolymer, Phenoxyethanol, Butyrospermum parkii (Shea) butter, Potassium cetyl phosphate, Tocopheryl acetate, Rosa canina fruit oil, Cetearyl alcohol,  Dimethiconol,  Sodium PCA, Methyparaben, Parfum(Fragrance) Xanthan gum, Ethylparaben, Dipropylene glycol, Ascorbyl glucoside,  Tetrasodium EDTA,  Magnesium PCA, T-butyl alcohol, Zinc PCA, Biosaccharide gum-1,  Potassium hydroxide, Manganese PCA,  Silica, Potassium sorbate.

  • INFORMATION FOR PATIENTS

    The Boots Company PLC Nottingham England NG2 3AA

    Dist. in the USA by Boots Retail USA Inc.

    New York NY 10005 

    www.boots.com/no7

  • Description

    5 STEPS TO RADIANCE

    1 x 15ml e 1 x 05 US Fl.Oz. 2 x 25ml e 2 x 0.84 Us Fl.Oz. 1 x 30ml e 1 x 1 US Fl.Ox 1 x 100ml e 1 x 3.3 Us Fl.Oz.

  • carton

    No7BeautSkinDC5StepsRadianceNo7BeautSkinDC5StepsRadiance

  • INGREDIENTS AND APPEARANCE
    NO7 BEAUTIFUL SKIN DAY CREAM NORMAL DRY SPF 15 
    avobenzone,octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 g  in 25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.5 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MANGANESE PCA (UNII: 3S6I84YKIV)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-132-011 in 1 CARTON05/20/2018
    125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/20/2018
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-132) , analysis(11489-132)
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