Label: DOTERRA SUN- zinc oxide stick

  • NDC Code(s): 71630-175-50
  • Packager: doTERRA International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Zinc Oxide 17.6%........................................ Sunscreen

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    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

    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.

  • WHEN USING

    For sunscreen use: • apply liberally 15 minutes before sun
    exposure • apply to all skin exposed to the sun • use a water
    resistant sunscreen if swimming or sweating • reapply at least
    every 2 hours.

  • STOP USE

    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 Control Center right away.

  • Directions

    Directions
    For sunscreen use: • apply liberally 15 minutes before sun
    exposure • apply to all skin exposed to the sun • use a water
    resistant sunscreen if swimming or sweating • reapply at least
    every 2 hours.

  • STORAGE AND HANDLING

    Other information • protect this product from excessive heat and
    direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients Heptyl Undecylenate, Simmondsia chinensis
    (Jojoba) Seed Oil, Euphorbia cerifera (Candelilla) Wax, Carthamus
    tinctorius (Safflower) Seed Oil, Theobroma cacao (Cocoa) Seed
    Butter, Jojoba Esters, Ethyl Macadamiate, Butyloctyl Salicylate,
    Oryzanol, Butyrospermum parkii (Shea) Butter, Daucus carota sativa
    (Carrot) Seed Oil, Boswellia carterii (Frankincense) Oil, Helichrysum
    italicum Flower/Leaf/Stem Oil, Cocos nucifera (Coconut) Fruit
    Extract, Helianthus annuus (Sunflower) Seed Oil, Bisabolol,
    Tocopherol, Phytosterols, Michelia alba (Magnolia) Leaf Oil,
    Cymbopogon flexuosus (Lemongrass) Oil, Squalene, Cananga
    odorata (Ylang Ylang) Flower Oil, Michelia alba (Magnolia) Flower
    Oil, Citrus nobilis (Mandarin Orange) Peel Oil

  • PRINCIPAL DISPLAY PANEL

    Tube Direct Stick LabelStick CartonMineral Sunscreen Stick
    Broad Spectrum SPF 40

  • INGREDIENTS AND APPEARANCE
    DOTERRA SUN 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    ORYZANOL (UNII: SST9XCL51M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    BUTYLOCTANOL (UNII: N442D9VO79)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    SQUALENE (UNII: 7QWM220FJH)  
    WATER (UNII: 059QF0KO0R)  
    MALIC ACID (UNII: 817L1N4CKP)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    COCONUT (UNII: 3RT3536DHY)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-175-5050 g in 1 TUBE; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2022
    Labeler - doTERRA International, LLC (832274935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(71630-175)
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