Label: NO7 RESTORE AND RENEW DAY CREAM 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 October 11, 2016

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

  • 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, Butyrospermum parkii (Shea) butter, Isostearyl isostearate, Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Glyeryl stearate, Tribehenin, Cetearyl alcohol, PEG-100 stearate, Ammonium acryloyldimethyltaurate/VP copolymer, Silica, Phenoxyethanol, Myristyl myristate, Rosa canina fruit 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 albus seed extract, Propylene glycol, Carbomer, Potassium hydroxide, Ceramide 3, Ethylhexylglycerin, Polysorbate 20, Ceramide 6 ll, Phytosphingosine, Tocopherol, Triethyl citrate, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide 1, CI77891(Titanium dioxide) CI 77491(Iron oxides), CI14700(Red 4)

  • INFORMATION FOR PATIENTS

    The Boots Company PLC Nottingham England NG2 3AA

    Dist. by Boots Retail USA Inc. New York NY 10005

    Made in the UK

    www.boots.com

  • Description

    Nourishes and revitalises maure skin to reveal younger looking, firmer feeling and more even toned skin in 4 weeks.

    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 fimer and has a renewed healthy glow.

    Our intensive nourishing complex containing an optimum blend of lipids works to deeply moisturise your skin and help strengthen its resilience to future dryness.

    For Best Results:

  • Carton

    No7RestoreandRenewDCCarton

  • INGREDIENTS AND APPEARANCE
    NO7 RESTORE AND RENEW DAY CREAM SPF 15 
    avobenzone,octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-109
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-109-011 in 1 CARTON10/11/2016
    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 finalpart35203/16/2016
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-109) , analysis(11489-109)