Label: NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15- octinoxate and avobenzone and ensulizole 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 2, 2010

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  • ACTIVE INGREDIENT

    Active ingredients

    Octinoxate (6.0%)

    Avobenzone (2.0%)

    Ensulizole (2.0%)

  • PURPOSE

    Purpose

    Sunscreens

    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 fabrics.
  • 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

    • After cleansing, massage over your face and neck, avoiding contact with 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 300C or 860F

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aqua (Water), Glycerin, Cyclopentasiloxane, Alcohol denat., Cyclohexasiloxane, C12-15 alkyl benzoate, Triethanolamine, Dimethicone, Acrylamide/ammonium acrylate copolymer, Cetyl alcohol, Myristyl myristate,  C18-36 acid glycol ester, Phenoxyethanol, Lauryl methacrylate/glycol dimethacrylate cross polymer, Polyisobutene, Glyceryl stearate, PEG-100 stearate, Betaine, Parfum (Fragrance), Dimethiconol, Methylparaben, Sodium 2-pyrrolidone-5-carboxylate, Xanthan gum, Ethylparaben, Sodium hyaluronate, Polysorbate 20, Dipropylene glycol, Sorbitol, Tetrasodium EDTA, Serine, Glycine, Glutamic acid, Lysine, BHT, Alanine, Arginine, Threonine, Propylparaben.

  • QUESTIONS

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

  • DESCRIPTION

    Balanced Hydration...

    Treat your skin to a long cool drink with this deliciously light lotion, created to work in harmony with oily to combination skin without blocking pores.

    The revolutionary water-based formula vanishes in to give your skin just the amount of moisture it needs.  At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

    With hyaluronic acid to keep skin hydrated for 24 hours, plus our ultra-light SPF 15 to care and protect.

    After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

    A little facial everyday...

    After cleansing, massage over your face and neck.  Apply prior to sun exposure.  Avoid direct contact with eyes.

    Dermatologically tested.

  • INFORMATION FOR PATIENTS

    Made in the UK

    The Boots Company PLC Nottingham England NG2 3AA

    Dist in the USA by Boots Retail USA Inc. Stamford CT06901

    www.boots.com

  • DESCRIPTION

    Bottle label

    Balanced Hydration...

    Treat your skin to a long cool drink with this light fluid, created for oily to combination skin without blocking pores.

    The water-based formula gives your skin just the amount of moisture it needs. At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

    With hyaluronic acid to keep skin hydrated for 24 hours.

    After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

    A little facial everyday...

    After cleansing, massage over your face and neck. 

    Apply prior to sun exposure.

    Avoid direct contact with eyes.

    Dermatologically tested.


  • ACTIVE INGREDIENT

    Active Ingredients:

    Octinoxate (6.0%)

    Avobenzone (2.0%)

    Ensulizole (2.0%)

  • INFORMATION FOR PATIENTS

    Made in the UK

    The Boots Company PLC Nottingham England NG2 3AA.

    Dist in the USA by Boots Retail USA Inc. Stamford CT06901

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

    www.boots.com

  • PRINCIPAL DISPLAY PANEL

    Carton label

    No7

    Rebalancing Day Fluid

    Oily/Combination

    Moisturises, mattifies and balances your skin

    Sunscreen SPF 15

    Hypo-allergenic

    Boots

    100ml e 3.3 US Fl. Oz

    Rebalancing Day Fluid carton.jpgRebalancing Day Fluid carton

  • PRINCIPAL DISPLAY PANEL

    No7 Rebalancing Day Fluid

    Oily/Combination

    Moisturises and mattifies your skin

    Sunscreen SPF 15

    Hypo-allergenic

    Boots

    100ml e 3.3 US Fl. Oz

    Rebalancing Day Fluid bottle.jpgRebalancing Day Fluid bottle

  • INGREDIENTS AND APPEARANCE
    NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 
    octinoxate and avobenzone and ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mL  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BETAINE (UNII: 3SCV180C9W)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    SERINE (UNII: 452VLY9402)  
    GLYCINE (UNII: TE7660XO1C)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LYSINE (UNII: K3Z4F929H6)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALANINE (UNII: OF5P57N2ZX)  
    ARGININE (UNII: 94ZLA3W45F)  
    THREONINE (UNII: 2ZD004190S)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-069-011 in 1 CARTON
    1100 mL in 1 BOTTLE, PUMP
    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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