Label: NO7 PROTECT AND PERFECT HAND CREAM SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate 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 1, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.0%

    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, hat 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), C12-15 alkyl benzoate, Glycerin, Butyrospermum parkii (shea) butter,C18-36 acid glycol ester, Glyceryl stearate, Cetearyl alcohol, PEG-100 stearate, Cyclopentasiloxane, Dimethicone, Polyacrylamide,   Cyclohexasiloxane, Phenoxyethanol, Tocopheryl acetate, C13-14 isoparaffin, Butylene glycol, Panthenol, Methylparaben, Parfum (Fragrance), Ethylparaben, Dimethiconol, Acrylates/vinyl isodecanoate crosspolymer, Laureth-7, Phytantiol, Undecylenyl phenylalanine, Dipropylene glycol, Potassium sorbate, Tetrasodium EDTA, Potassium hydroxide, Lupinus albus seed extract, Carbomer, Agarum cribosum, Polysorbate 20, BHT,  Butylparaben, Propylparaben, Palmitoyl oligopeptide, Isobutylparaben, Palmitoyl tetrapeptide-7

  • QUESTIONS

    USA: Questions? 1-866-75-BOOTS

  • DESCRIPTION


    Appear younger longer.
    This quickly and easily absorbed moisturiser vanishes to reveal beautifully younger looking hands with fine lines reduced in just 2 weeks.
    Contains our unique whitening complex to help fade age spots and lipo-peptides to help boost and maintain elasticity. Hands remain conditioned even after washing. Formulates with pro-vitamin B5 to help strengthen nails and moisturise cuticles. SPF 15 helps protect against the ageing effects of the sun.
    Hypo-allergenic: Because all skin can have sensitive moments all our products are hypo-allergenic using ingredients we known and trust.
    A little beauty treatment everyday.
  • 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/no7

  • INSTRUCTIONS FOR USE

    Smooth into hands every morning and any time they need a little extra care.
  • ACTIVE INGREDIENT

    TUBE TEXT

    Active ingredients: Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.0%

  • WARNINGS

    TUBE TEXT

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

  • INDICATIONS & USAGE

    TUBE TEXT

    Smooth into hands every morning and any time they need a little extra care.

  • INFORMATION FOR PATIENTS

    TUBE TEXT


    The Boots Company PLC Nottingham England NG2 3AA

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

    Made in the UK
    www.Boots.com/no7

  • DESCRIPTION

    TUBE TEXT

    Appear younger longer.
    This quickly and easily absorbed moisturiser vanishes to reveal beautifully younger looking hands with fine lines appearing reduced in just 2 weeks. Contains our unique whitening complex to help fade age spots and lipo-peptides to help boost and maintain elasticity. Hands remain conditioned even after washing. Formulates with Pro-Vitamin B5 to help strengthen nails and moisturise cuticles. SPF 15 helps protect against the ageing effects of the sun.
    A little beauty treatment everyday.
  • PRINCIPAL DISPLAY PANEL

    No7 Protect and Perfect
    Hand Cream
    Conditions and protects for younger looking hands
    Sunscreen Broad Spectrum SPF 15
    75ml 2.5 US Fl.Oz.
    No7 PP Hand Cream SPF 15 carton.jpg
    No7 PP Hand Cream SPF 15 carton
  • PRINCIPAL DISPLAY PANEL

    No7 Protect and Perfect

    Hand Cream

    Conditions and protects for younger looking hands

    Sunscreen Broad Spectrum SPF 15

    Hypo-allergenic

    75ml 2.5 US Fl.Oz.

    No7 PP Hand Cream SPF 15 tube.jpgNo7 PP Hand Cream SPF 15 tube

  • INGREDIENTS AND APPEARANCE
    NO7 PROTECT AND PERFECT HAND CREAM SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.25 mL  in 75 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate5.625 mL  in 75 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.5 mL  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Glycerin (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    potassium hydroxide (UNII: WZH3C48M4T)  
    LUPINUS ALBUS SEED (UNII: 24GB753W3B)  
    AGARUM CLATHRATUM (UNII: IW3259E99T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68472-111-011 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2012
    Labeler - Boots Retail USA Inc (143151533)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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