Label: BOTANICS DAILY HAND THERAPY SUNSCREEN SPF 10- octinoxate and avobenzone 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 7, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                  Purpose

    Avobenzone 2%                     Sunscreens

    Octinoxate 4%

  • PURPOSE

    Uses

    • Provides minimal 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.

  • HOW SUPPLIED

    Colour may vary due to natural extracts

  • ASK DOCTOR

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions

    • Massage into hands daily
    • 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, Butylene glycol, Dimethicone, Cetyl alcohol, Paraffinum liquidum (Mineral oil), Sorbitan stearate, Petrolatum, C18-36 acid glycol ester, Glycerin, Butyrospermum parkii (Shea butter), Phenoxyethanol, Vaccinium myrtillus extract, Carbomer, Methylparaben, Xanthan gum, Parfum (Fragrance), Propylparaben, Potassium hydroxide, Sucrose cocoate, Equisetum arvense extract, Dipropylene glycol, Tetrasodium EDTA, BHT

  • QUESTIONS

    USA: Questions? 1-866-75-BOOTS

  • DESCRIPTION

    EXTRACTS AUTHENTICATED BY ROYAL BOTANIC GARDENS KEW

    ACTIVE PLANT EXTRACTS

    Plant extracts at levels that really work, combined and formulated for unbeatable product performance.

    Naturally.

    Hands show the signs of ageing just as much as the face.  This light cream helps protect hands from free radical damage and premature skin ageing.  Easily absorbed so you can use it all day long, it sinks into skin to plump and moisturise leaving your hands beautifully soft, smooth and supple.

    Dermatologically tested.

  • INFORMATION FOR PATIENTS

    Mfd in the U.K. for BBI NG2 3AA. UK.

    Dist in the USA by Boots Retail USA Inc. Stamford CT 06901

    USA: Questions? 1-866-75-BOOTS

    www.boots.com

  • DESCRIPTION

    Tube label

    ACTIVE PLANT EXTRACTS

    Plant extract at levels that really work.  Naturally. 

    This light cream helps protect hands from free radical damage and premature skin ageing.  Easily absorbed so you can use it all day long.

    Dermatologically tested.


    EXTRAITS ACTIFS DE PLANTES

    Des extraits de plantes à des degrés efficaces.  Tout naturellement.

    Cette crème légère aide à protéger les main des radicaux libres et lutte contre le vieillissement prematuré.  Facilement absorbée, elle peau être utilisée tout au long de la journée.

    Dermo-testé
  • INDICATIONS & USAGE

    DIRECTIONS: Massage into hands daily.

    MODE D'EMPLOI: Massage des main au quotidian.

  • WARNINGS AND PRECAUTIONS

    WARNINGS: Avoid getting directly in eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

    MISE EN GARDE: Éviter tout contact avec les yeux.  En cas de projection, rincer immédiatement à l'eau froide.  Éviter tout contact direct avec du tissu.

  • HOW SUPPLIED


    Colour may vary due to natural extracts.

    La couleur peut varier en raison des extraits naturels.
  • ACTIVE INGREDIENT


    ACTIVE INGREDIENTS/ACTIFS: Octinoxate 4.0%  Avobenzone 2.0%.
  • INFORMATION FOR PATIENTS

    EXTRACTS AUTHENTICATED BY ROYAL BOTANIC GARDENS KEW

    EXTRAITS APPROUVES PAR LES JARDINS BOTANIQUES ROYAUX DE KEW

    Mfd in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK.

    Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901

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

    www.boots.com

  • PRINCIPAL DISPLAY PANEL

    Carton label

    Daily Hand Therapy Sunscreen SPF 10

    Bilberry to protect and brighten

    Cure Quotidienne Des Main Protection Solaire FPS 10

    La myrtille protège et éclaircit

    Boots

    The Power of Plants

    Botanics

    75ml e 2.5 US Fl. Oz

    Daily Hand Therapy carton.jpgDaily Hand Therapy carton

  • PRINCIPAL DISPLAY PANEL

    Tube label

    Daily Hand Therapy Sunscreen SPF 10

    Bilberry to protect and brighten

    Cure Quotidienne Des Main Protection Solaire FPS 10

    La myrtille protège et éclaircit

    Boots

    The Power of Plants

    Botanics

    75ml e 2.5 US Fl. Oz

    Daily Hand Therapy label.jpgDaily Hand Therapy label

  • INGREDIENTS AND APPEARANCE
    BOTANICS DAILY HAND THERAPY SUNSCREEN SPF 10 
    octinoxate and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.00 mL  in 75 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.5 mL  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Shea Butter (UNII: K49155WL9Y)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Vaccinium Myrtillus Leaf (UNII: Y4U591OU70)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-056-011 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2010
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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