Label: NO7 PROTECT AND PERFECT HAND SUNSCREEN SPF 15- octinoxate, avobenzone and 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 December 2, 2010

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  • ACTIVE INGREDIENT

    NO7 PROTECT AND PERFECT HAND CREAM SUNSCREEN SPF 15

    Active ingredients                                 Purpose

    Octinoxate (7.5%)                                   Sunscreens

    Avobenzone (3.0%)

    Octisalate (2.0%)

  • PURPOSE

    Uses

    • Provides moderate protection against the adverse effects of the sun
    • Higher SPF gives more protection
  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only

    When using this product

    • Keep out of eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.
  • ASK DOCTOR

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of children.  If swallowed, get medical help.

  • INDICATIONS & USAGE

    Directions

    • After cleansing, applying Protect and Perfect Hand Cream, simply smooth into your hands, avoiding contact your eyes.
    • Apply evenly at least 15 minutes before sun exposure
    • Reapply as required
    • Not intended for children under the age of 12
    • Not intended for protection while sunbathing
  • STORAGE AND HANDLING

    Other information

    Do not store above 30oC or 86oF

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    USA/Canada: 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 appearing reduced in just 2 weeks.  Contains our patented whitening complex to help fade age spots and lipo-peptides to help boost and maintain elasticity.  Hands remain conditioned even after washing.  Formulated with Pro-Vitamin B5 to help strengthen nails and moisturise cuticles.  SPF 15 helps protect against the ageing effects of the sun.

    A little manicure every day ...

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

    Dermatologically tested


  • INFORMATION FOR PATIENTS

    Mfd in the UK/Fabriqué au R.-U

    The Boots Company PLC Nottingham England NG2 3AA

    Dist in the US by/aux É.-U par

    Boots Retail USA Inc. Stamford CT06901

    USA/Canada: Questions? 1-866-75-Boots

    www.boots.com

  • DESCRIPTION

    Tube label

    Appear Young 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 patented whitening complex to help fade age spots and lipo-peptides to help boost and maintain elasticity.  Hands remain conditioned even after washing.  Formulated with Pro-Vitamin B5 to help strengthen nails and moisturise cuticles.  SPF 15 helps protect against the ageing effects of the sun.

    A little manicure every day...

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

    Avoid contact with eyes.  If contact occurs rinse thoroughly with cold water.
  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinoxate (7.5%), Avobenzone (3.0%), Octisalate (2.0%)

  • INFORMATION FOR PATIENTS


    Mdf in the UK for/Fabriqué au R.-U.

    The Boots Company PLC Nottingham England NG2 3AA

    Dist in the USA by/aux É.U. par Boots Retail USA Inc. Stamford CT06901

    USA/Canada: Questions? 1-866-75-BOOTS

    www.boots.com
  • PRINCIPAL DISPLAY PANEL

    Carton label

    No7 Protect and Perfect

    Protection et Perfection

    Hand Cream/Crème pour les mains

    Conditions and protects for younger looking hands

    Sunscreen SPF 15

    Hypo-allergenic

    Boots

    75ml e 2.5 US Fl. Oz

    P and P Hand Cream carton.jpg
    P and P Hand Cream carton
  • PRINCIPAL DISPLAY PANEL

    Tube label

    No7

    Protect and Perfect

    Protection et Perfection

    Hand Cream

    Crème pour les mains

    Conditions and protects for younger looking hands

    Sunscreen SPF 15

    Hypo-allergenic

    Boots

    75ml e 2.5 US Fl. Oz

    P and P Hand Cream tube.jpgP and P Hand Cream tube

  • INGREDIENTS AND APPEARANCE
    NO7 PROTECT AND PERFECT HAND SUNSCREEN SPF 15 
    octinoxate, avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.625 mL  in 75 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.25 mL  in 75 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 mL  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-068-011 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/04/2009
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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