Label: NO7 EARLY DEFENCE DAY CREAM- 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 February 1, 2016

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

  • Carton Active Ingredients Section

    Active ingredients

    Avobenzone 3%

    Octisalate 5%

    Octocrylene 7.5%

  • 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  benzoate,Tribehenin, Alcohol denat, Dimethicone, Aluminum starch octenylsuccinate, Cetearyl glucoside, Butyrospermum parkii(Shea)butter, Ammonium acryloydimethyltaurate/VP copolymer, Phenoxyethanol, Potassium cetyl phosphate, Methylparaben, Parfum(Fragrance), Butylene glycol, Dimethiconol, Propylene glycol, Xanthan gum, Tocopheryl acetate, Ascorbyl glucoside, Ethylparaben, Retinyl palmitate, Hydrolyzed rice protein, Tetrasodium EDTA, T-butyl alcohol, Panax ginseng root extract, Dimethylmethoxy chromanol, Medicago sativa(Alfalfa) extract, Carbomer, Potassium hydroxide, Polysorbate 20, Morus alba leaf extract, Silica, Isopropyl myristate, Sodium benzoate, Tocopherol, Ethylhexylglycerin, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7

  • Description

    Protects and boosts young skin's natural defences to help it look younger for longer.

    This super light and non-pore blocking day cream is especially designed for young skin.

    Unique Double Defence technology protects skin and boosts natural defences to help it look younger for longer. The protective power of Broad Spectrum SPF30 gives skin advanced protection from the sun and environmental stress. Lipopeptides and Vitamin A help reduce the appearance of first fine lines.

    Use every morning after cleansing, massage in small upward circles over face and neck,avoiding the delicate eye area.

  • INFORMATION FOR PATIENTS

    Made in the UK

    The Boots Company PLC Nottingham England NG2 3AA

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

    www.boots.com

  • carton

    No7EarlyDefenceDayCreamSPF30carton

  • INGREDIENTS AND APPEARANCE
    NO7 EARLY DEFENCE DAY CREAM 
    avobenzone,octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.75 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MEDICAGO SATIVA LEAF (UNII: HY3L927V6M)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-097-011 in 1 CARTON
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2016
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-097) , analysis(11489-097)