Label: SAGE AND ZINC FACIAL HYDRATING SPF 15- zinc oxide 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 November 17, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide 16.1%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

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

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

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
    • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, PEG-100 Stearate, Glycerin, Cetearyl Alcohol, Potassium Cetyl Phosphate, Macadamia Ternifolia Seed Oil, Squalane, Hydrogenated Palm Glycerides, Phenoxyethanol, Tocopheryl Acetate, Lauryl Pyrrolidone, Oenothera Biennis (Evening Primrose) Oil, Silica, Citric Acid, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Salvia Officinalis (Sage) Oil, Tocopherol, Disodium EDTA, Xanthan Gum, Glycine Soja (Soybean) Oil, Fusanus Spicatus Wood Oil, Caprylyl Glycol, Magnesium Aluminum Silicate, Ethylhexylglycerin, Glycine Soja (Soybean) Seed Extract, Daucus Carota Sativa (Carrot) Root Extract, Beta-Carotene.

  • SPL UNCLASSIFIED SECTION

    Manufactured in Australia.
    Aesop, 25 Smith Street, Fitzroy 3065 Australia.

  • PRINCIPAL DISPLAY PANEL - 47 g Tube Carton

    Aēsop®

    Sage & Zinc Facial Hydrating Cream with Sunscreen
    SPF
    15

    Zinc Oxide • Tocopheryl Acetate • Sage Leaf

    Daily moisturising sunscreen SPF15 for all skin types. A hydrating blend of superior botanicals including Sage Leaf and
    Sandalwood, with the benefits of Zinc Oxide.

    Massage evenly over the face from forehead to neck after cleansing and reapply during the day to maintain protection. Enhanced
    with plant-derived vitamins including Vitamin E, this cream with mineral-based sunscreen is ideal for city living.

    www.aesop.com
    Net Wt. 47 g / 1.6 Oz.

    Principal Display Panel - 47 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SAGE AND ZINC FACIAL HYDRATING  SPF 15
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76293-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.26 g  in 1.54 g
    Inactive Ingredients
    Ingredient NameStrength
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Water (UNII: 059QF0KO0R)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Macadamia Oil (UNII: 515610SU8C)  
    Squalane (UNII: GW89575KF9)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)  
    Lauryl Pyrrolidone (UNII: 3P14VW8FNY)  
    Evening Primrose Oil (UNII: 3Q9L08K71N)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Sage Oil (UNII: U27K0H1H2O)  
    Tocopherol (UNII: R0ZB2556P8)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Soybean Oil (UNII: 241ATL177A)  
    Santalum Spicatum Oil (UNII: H9LVS6REV4)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Soybean (UNII: L7HT8F1ZOD)  
    Carrot (UNII: L56Z1JK48B)  
    Beta Carotene (UNII: 01YAE03M7J)  
    Product Characteristics
    ColorYELLOW (Pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76293-037-5612 in 1 CARTON
    1NDC:76293-037-7471 g in 1 JAR
    2NDC:76293-037-6324 in 1 CARTON
    2NDC:76293-037-4247 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2012
    Labeler - Emeis Cosmetics Pty Ltd (754271146)
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