Label: BOTANICS PROTECTING DAY AGE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene 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 December 21, 2012

If you are a consumer or patient please visit this version.

  • Carton Active Ingredients Section

    Active Ingredients

    Avobenzone 3%

    Octisalate 3%

    Octocrylene 5%

    Purpose Sunscreen

  • Uses

    Uses - helps prevent sunburn.

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove

  • Ask a doctor

    Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Centre right away.

  • Directions

    Directions for sunscreen use

    apply liberally 15 minutes before sun exposure

    reapply at least every 2 hours

    use a water resistant sunscreen if swimming or sweating

    children under 6 months of age: Ask a doctor

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m. – 2 p.m.

    wear long-sleeved shirts, pants, hats, and sunglasses

  • Storage

    Other information - protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl glucoside, Prunus amygdalus dulcis (Sweet almond) oil, Tribehenin, Butyrospermum parkii (Shea) butter, Cetearyl alcohol, Sodium polyacrylate, Potassium cetyl phosphate, Phenoxyethanol, Globularia cordifolia callus extract, Xanthan gum, Dimethicone crosspolymer, Caprylyl glycol, Citric acid, Parfum (Fragrance), Dipropylene glycol, Sodium benzoate, Tocopheryl acetate, Hydrolyzed hyaluronic acid, Ginkgo biloba leaf extract, Ascorbyl glucoside, Retinyl palmitate, Ethylhexylglycerin, Tetrasodium EDTA, Limonene, Cupressus funebris wood oil, Hexyl cinnamal, Linalool, Potassium hydroxide, Citral, Simethicone, Tocopherol, Potassium sorbate, Tagetes minuta flower oil

  • Description

    This unique anti-aging complex includes provitamin A and targeted hyaluronic acid to deeply hydrate. Plant stem technology works to enhance skin's radiance.

    Active plant extract, Ginkgo, is packed with anti-oxidants that work to protect skin from external damage, helping skin look younger for longer.

    Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.

  • Information

    Made in the UK.

    The Boots Company PLC Nottingham England NG2 3AA

    Dist. in the USA by Boots Retain USA Inc. Norwalk CT 06851 USA

    www.boots.com

  • Jar label

    Boots Botanics The Power of Plants

    Protecting Day Cream Sunscreen Broad Spectrum SPF 15

    50ml e 1.69 US Fl. Oz.

    Active ingredients: Avobenzone 3%, Octisalate 3%, Octocrylene 5%

  • Warnings

    Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately.

  • Description

    Directions: Use every morning after cleansing

  • Information

    The Boots Company PLC

    Notingham England NG2 3AA

    Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA

    Made in the UK

    www.boots.com

  • Carton

    cartonCarton

  • INGREDIENTS AND APPEARANCE
    BOTANICS PROTECTING DAY AGE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.5 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINKGO (UNII: 19FUJ2C58T)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TAGETES MINUTA FLOWER OIL (UNII: 1T0ZMU8M8B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-083-011 in 1 CARTON
    150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/14/2013
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company Plc (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-083) , analysis(11489-083)