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Name:Botanics Complexion Refining Day Moisture Sunscreen Spf 12
Manufacturer:Bcm Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Carton and tube labelling

BOTANICS COMPLEXION REFINING DAY MOISTURE SUNSCREEN SPF 12  - octinoxate and avobenzone lotion 
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

BOTANICS COMPLEXION REFINING DAY MOISTURE LOTION SUNSCREEN SPF 12

Active Ingredients                  Purpose

Avobenzone 3%                     Sunscreens

Octinoxate 5%

Uses

  • Provides moderate 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 onto face and neck with gentle upward strokes.
  • 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, Glycerin, Sorbitan stearate, Cetyl alcohol, C18-36 acid glycol ester, Kaolin, Rosmarinus officinalis (Rosemary) leaf extract, Phenoxyethanol, Butyrospermum parkii (Shea butter), Lauryl methacrylate/glycol dimethacrylate cross polymer, Methylparaben, Carbomer, Propylparaben, Sucrose cocoate, Xanthan gum, Limonene, Parfum (Fragrance), Potassium hydroxide, Butylparaben, Ethylparaben, Linalool, Tetrasodium EDTA, Isobutylparaben, Dipropylene glycol, Citronellol, Zinc chloride, BHT, Tetrasodium pyrophosphate, Cinnamyl alcohol, Citral

USA: Questions? 1-866-75-BOOTS

ACTIVE PLANT EXTRACTS

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

Naturally.

Ideal for Blemish Prone Skin

Skin needs moisture, but too much oil can clog pores and lead to blemishes.  This light lotion hydrates and helps to soothe the skin while oil absorbing powders help to reduce shine. 

Oil Free. Non-pore blocking.

Dermatologically tested.

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

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

www.boots.com

Tube label

ACTIVE PLANT EXTRACTS

Plant extract at levels that really work, combined and formulated for outstanding product performance.  Naturally. 

This light lotion hydrates and soothes the skin while oil absorbing powders help to reduce shine. 

Oil free.  Non-pore blocking.  SPF 12.

Dermatologically tested.


EXTRAITS ACTIFS DE PLANTES

Des extraits de plantes à des degrés efficaces, agencés et formulés pour un produit d'une performance exceptionnelle. Tout naturellement.

Cette lotion légère hydrate et aide à adoucir la peau pendant que les poudres absorbantes contribuent à réduire le lustre. 

Sans huile.  N'obstrue pas les pores.  FPS 12.

Dermo-testé

DIRECTIONS: Massage onto face and neck using gentle upward strokes.

MODE D'EMPLOI: Massez sur le visage et le cou en suivant des mouvements ascendants.

Active ingredients: Avobenzone 3.0%, Octinoxate 5.0%

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.


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

COMPLEXION REFINING

Day Moisture Lotion Sunscreen SPF 12

Rosemary protects and clarifies

AFFINAGE DU TEINT

Lotion Hydratante Jour FPS12

Le Romarin protège et éclaircit

BOOTS

The Power of Plants

BOTANICS

75ml e 2.5 US Fl. Oz

../images_otc/botanics_com_CR Day Moisture Lotion carton.jpgCR Day Moisture Lotion carton

Day Moisture Lotion Sunscreen SPF 12

Rosemary protects and clarifies

Lotion Hydratante Jouse FPS12

Le Romarin protège et éclaircit

Boots

The Power of Plants

BOTANICS

75ml e 2.5 US Fl. Oz

../images_otc/botanics_com_CR Day Moisture Lotion label.jpgCR Day Moisture Lotion label


BOTANICS COMPLEXION REFINING DAY MOISTURE SUNSCREEN SPF 12 
octinoxate and avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-060
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 3.75 mL  in 75 mL
Avobenzone (Avobenzone) Avobenzone 2.25 mL  in 75 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Butylene Glycol  
Dimethicone  
Glycerin  
Sorbitan Monostearate  
Cetyl Alcohol  
Kaolin  
Rosemary  
Phenoxyethanol  
Shea Butter  
Methylparaben  
Carbomer Homopolymer Type C  
Propylparaben  
Xanthan Gum  
Potassium Hydroxide  
Butylparaben  
Ethylparaben  
Isobutylparaben  
Zinc Chloride  
Butylated Hydroxytoluene  
Sodium Pyrophosphate  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11489-060-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 75 mL in 1 TUBE This package is contained within the CARTON (11489-060-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/27/2010

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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