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

  • 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 8, 2010

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  • ACTIVE INGREDIENT

    BOTANICS COMPLEXION REFINING DAY MOISTURE LOTION SUNSCREEN SPF 12

    Active Ingredients                  Purpose

    Avobenzone 3%                     Sunscreens

    Octinoxate 5%

  • 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.

  • 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 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.
  • 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, 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

  • QUESTIONS

    USA: Questions? 1-866-75-BOOTS

  • DESCRIPTION

    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.

  • 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

    www.boots.com

  • DESCRIPTION

    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
  • INDICATIONS & USAGE

    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 INGREDIENT

    Active ingredients: Avobenzone 3.0%, Octinoxate 5.0%

  • 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.


  • 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

    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

    CR Day Moisture Lotion carton.jpgCR Day Moisture Lotion carton

  • PRINCIPAL DISPLAY PANEL

    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

    CR Day Moisture Lotion label.jpgCR Day Moisture Lotion label

  • INGREDIENTS AND APPEARANCE
    BOTANICS COMPLEXION REFINING DAY MOISTURE SUNSCREEN SPF 12 
    octinoxate and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 mL  in 75 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.25 mL  in 75 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Kaolin (UNII: 24H4NWX5CO)  
    Rosemary (UNII: IJ67X351P9)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Shea Butter (UNII: K49155WL9Y)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Ethylparaben (UNII: 14255EXE39)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-060-011 in 1 CARTON
    175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/27/2010
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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