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Name:Botanics Daily Hand Therapy Sunscreen Spf 10
Manufacturer:Bcm Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Carton and tube labelling

BOTANICS DAILY HAND THERAPY SUNSCREEN SPF 10  - octinoxate and avobenzone cream 
BCM Ltd

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.

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Carton and tube labelling

Active Ingredients                  Purpose

Avobenzone 2%                     Sunscreens

Octinoxate 4%

Uses

  • Provides minimal protection against the adverse effects of the sun
  • Higher SPF gives more protection

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.

Colour may vary due to natural extracts

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

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

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.

Other Information

Do not store above 30oC or 86oF.

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

USA: Questions? 1-866-75-BOOTS

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.

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

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

DIRECTIONS: Massage into hands daily.

MODE D'EMPLOI: Massage des main au quotidian.

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.


Colour may vary due to natural extracts.

La couleur peut varier en raison des extraits naturels.


ACTIVE INGREDIENTS/ACTIFS: Octinoxate 4.0%  Avobenzone 2.0%.

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

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

../images_otc/botanics_dai_Daily Hand Therapy carton.jpgDaily Hand Therapy carton

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

../images_otc/botanics_dai_Daily Hand Therapy label.jpgDaily Hand Therapy label


BOTANICS DAILY HAND THERAPY SUNSCREEN SPF 10 
octinoxate and avobenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-056
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 3.00 mL  in 75 mL
Avobenzone (Avobenzone) Avobenzone 1.5 mL  in 75 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Butylene Glycol  
Dimethicone  
Cetyl Alcohol  
Mineral Oil  
Sorbitan Monostearate  
Petrolatum  
Glycerin  
Shea Butter  
Phenoxyethanol  
Vaccinium Myrtillus Leaf  
Carbomer Homopolymer Type C  
Methylparaben  
Xanthan Gum  
Propylparaben  
Potassium Hydroxide  
Butylated Hydroxytoluene  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11489-056-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 75 mL in 1 TUBE This package is contained within the CARTON (11489-056-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2010

Labeler - BCM Ltd (230780322)
Registrant - The Boots Company PLC (218622660)
Establishment
Name Address ID/FEI Operations
BCM Ltd 230780322 manufacture, analysis

Revised: 12/2010 BCM Ltd



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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