Label: NO7 RESTORE AND RENEW DAY SUNSCREEN- 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 10, 2012

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

  • 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 Center right away

  • Directions

    Directions for sunscreen use

    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 eraly skin aging. Todecrease 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,hates, and sunglasses

  • Storage

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

  • Inactive ingredients

    Aqua ( Water ), Glycerin, C12-15 alkyl benzoate,Butrospermum parkii (Shea) butter, Isostearyl isostearate, Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Glyceryl stearate, Tribehenin, Cetearyl alcohol, PEG-100 stearate, Ammonium acryloydimethyltaurate/VP copolymer, Silica, Phenoxyethanol,Myristyl myristate, Rosa moschata seed oil, Dimethiconol, Butylene glycol, Methylparaben, Parfum ( Fragrance ), Xanthan gum, Ethylparaben, Sodium lauroyl lactylate, Ascorbyl glucoside, Retinyl palmitate, Diospyros kaki calyx extract, Cholesterol, Tetrasodium EDTA, T-butyl-alcohol, Lupinus seed extract, Propylene glycol, carbomer, Potassium hydroxide, Ceramide 3, Ethylhexylglycerin, Polysorbate 20, Ceramide 6 II, Phytosphingosine, Tocopherol, Triethyl citrate, Palmitoyl oligopeptide, Palmitoyl tetrapeptide-7,Ascorbyl palmitate, Ceramide 1, CI 77891 ( Titanium dioxide ),CI 77491 (iron oxides), CI 14700 (Red4)

  • Description

    Nourish and revitalise your skin with this protecting and replenishing daytime formula. Created to provide day long hydration, replenish lost lipids and help boost your skin's repair and recovery processes.The result is smoother, plumper looking skin that feels firmer and has a renewed healthy glow. Our inensive noursihing complex containing an optimum blend of lipids works to deeply moisturise your skin and help strengthen its resilience to future dryness.

    For Best Results: After claensing, simply smooth into your face and neck with your fingertips, avoiding your eyes.

  • Information

    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 Active Ingredients Section

    Active Ingredients

    Avobenzone 3%

    Octisalate 2%

    Octocrylene 4%

    Purpose Sunscreen

  • Uses

    Uses - helps prevent sunburn

  • Printed jar

    No7 Restore and Renew Day Cream Sunscreen Broad Spectrum SPF 15

    50ml e 1.6 US Fl.Oz.

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

  • Warning

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

  • Description

    smooth into your face and neck after applying your No7 serum

  • Information

    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

    cartoncarton

  • INGREDIENTS AND APPEARANCE
    NO7 RESTORE AND RENEW DAY SUNSCREEN 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-078-011 in 1 CARTON
    150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/10/2012
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-078) , analysis(11489-078)