Label: BOTANICS DAY MOISTURE SUNSCREEN SPF 12- octinoxate, avobenzone and octisalate 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 August 3, 2010

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  • ACTIVE INGREDIENT

    BOTANICS DAY MOISTURE CREAM SUNSCREEN SPF 12

    Active Ingredients      Purpose

    Avobenzone 3%            Sunscreens
    Octinoxate 7.5%
    Octisalate 2.5%

    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.
    Rinse with water to remove.
  • 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

    • Gently massage onto face and neck.
    • 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), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Apha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

  • QUESTIONS

    USA Questions?1-866-75-BOOTS

  • DESCRIPTION

    Plant extracts at levels that really work.

    This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target skin ageing.

    Dermatologically tested


  • INFORMATION FOR PATIENTS

    Mfd in the UK for Boots Beauty International Limited

    NG2 3AA. UK

    Dist in the USA by Boots Retail USA Inc.

    Stamford CT 06901

    USA: Questions? 1-866-75-BOOTS

    www.boots.com

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.5%.


  • INACTIVE INGREDIENT

    IN-ACTIVE INGREDIENTS: Aqua (Water), Glycerin, Butylene glycol, Caprylic/capric triglyceride, PPG-15 stearyl ether, Dimethicone, Steareth-21, Mel (Honey), Cetyl alcohol, Steareth-2, Polyacrylamide, Phenoxyethanol, C13-14 isoparaffin, Hydrolyzed rice bran protein, Methylparaben, Parfum (Fragrance), Sodium benzoate, Laureth-7, Propylparaben, Citric acid, Sodium chloride, Tetrasodium EDTA, Linalool, Benzyl salicylate, BHT, Sodium citrate, Hexyl cinnamal, Limonene, Hydroxycitronellal, Citronellol, Geraniol, Dipropylene glycol, Alpha-isomethyl ionone, Ethylparaben, Butylparaben, Isobutylparaben, CI 19140 (Yellow 5).

  • INFORMATION FOR PATIENTS

    Mfd in the UK for BBI Ltd 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

    Plant extracts at levels that really work.

    This rich, indulgent cream instantly hydrates then continues to top up the skin's natural moisture level for up to 12 hours. With honey and rice extract to restore, plump and smooth your skin. With UVA/UVB SPF12 protection to target premature skin ageing.

    Dermatologically tested.

  • INDICATIONS & USAGE

    Directions: Use daily, alone or under make up, following your cleansing routine. Massage onto skin using upward strokes.

    Colour may vary due to natural extracts.

  • WARNINGS AND PRECAUTIONS

    Warnings: Avoid contact with eyes. May cause irritation.

    If contact occurs, rinse immediately with cold water.

    If irritation persists, consult your physician immediately.

    Avoid direct contact with fabric.

  • PRINCIPAL DISPLAY PANEL

    The Power of Plants

    BOTANICS

    DAY MOISTURE CREAM

    Sunscreen SPF 12

    With hydrating rice extract and honey to

    restore, plump and smooth your skin.

    50ml e 1.69 US Fl. Oz.Day Moisture Cream carton

  • PRINCIPAL DISPLAY PANEL

    The Power of Plants

    BOTANICS

    DAY MOISTURE CREAM

    Sunscreen SPF 12

    With hydrating rice extract and honey.

    50ml e 1.69 US Fl. Oz.Day Moisture Cream label

  • HOW SUPPLIED

    Colour may vary due to natural extracts.

  • INGREDIENTS AND APPEARANCE
    BOTANICS DAY MOISTURE SUNSCREEN SPF 12 
    octinoxate, avobenzone and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.25 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HONEY (UNII: Y9H1V576FH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    RICE BRAN (UNII: R60QEP13IC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68472-074-011 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/25/2010
    Labeler - Boots Retail USA Inc (143151533)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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