Label: SAGE AND ZINC FACIAL HYDRATING SPF15- zinc oxide lotion

  • NDC Code(s): 76293-372-01
  • Packager: Emeis Cosmetics Pty Ltd
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 23, 2021

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  • Drug Facts

  • Active ingredient

    Zinc Oxide 19.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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.

    Stop use and ask a doctor

    if rash occurs.

    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.
    • Children under 6 months of age: Ask a doctor.
    • Reapply:
    • At least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Sun Protection Measures. Spending time in the sun increases 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-sleeve shirts, pants, hats and sunglasses.
  • 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 (Aqua), Glycerin, Coco-Caprylate/Caprate, Octyldodecanol, Acrylates Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Macadamia Integrifolia Seed Oil, Squalane, Polyglyceryl-3 Polyricinoleate, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Tocopheryl Acetate, Saccharide Isomerate, Oenothera Biennis (Evening Primrose) Oil, Silica, Isostearic Acid, Lavandula Angustifolia (Lavender) Oil, Glycine Soja (Soybean) Oil, Salvia Officinalis (Sage) Oil, 1,2-Hexanediol, Caprylyl Glycol, Sodium Gluconate, Fusanus Spicatus Wood Oil, Tocopherol, Polysorbate 60, Sorbitan Isostearate, Ethylhexylglycerin, Calcium Chloride, Glycine Soja (Soybean) Seed Extract, Citric Acid, Sodium Citrate, Potassium Sorbate, Xylose, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Linalool, Farnesol, Limonene, Geraniol.

  • Company Information

    Manufactured in Australia.

    Aesop, 25 Smith Street,

    Fitzroy 3065, Australia.

    +61 3 9412 8900

    aesop@aesop.com

    Distributed by Aesop USA Inc,

    48 West 25th St. New York, NY,

    10010

  • Product Packaging

    Aesop.

    SPF 15 Sage & Zinc Facial Hydrating Lotion

    Zinc Oxide

    Tocopheryl Acetate

    Sage Leaf

    Broad-spectrum SPF15 Sunscreen

    Daily-use moisturiser providing mineral-based, SPF15 sunscreen protection. Suitable for most skin types, including sensitive. Massage evenly over the face and neck after cleansing and reapply during the day to maintain protection

    aesop.com

    Net wt. 57 g/2.0Oz.

    sage and zinc

  • INGREDIENTS AND APPEARANCE
    SAGE AND ZINC FACIAL HYDRATING SPF15 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76293-372
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE195 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XYLOSE (UNII: A1TA934AKO)  
    CARROT (UNII: L56Z1JK48B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SAGE OIL (UNII: U27K0H1H2O)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    LUVISET 360 (UNII: 05BG6GY6YK)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    FARNESOL (UNII: EB41QIU6JL)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GERANIOL (UNII: L837108USY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SQUALANE (UNII: GW89575KF9)  
    OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76293-372-011 in 1 CARTON01/01/2022
    157 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2022
    Labeler - Emeis Cosmetics Pty Ltd (754271146)