Label: DOTERRA SUN- zinc oxide spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 16, 2022

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  • ACTIVE INGREDIENT

    Active ingredient(s) Zinc Oxide 16.4%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    helps prevent sunburn, if used as directed with othe rsn protection measures, 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.

  • 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.
    *children under 6 months of age: ask a doctor

  • 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

    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.

  • Other information

    protect this product from excessive heat and direct sun.protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Water (Aqua), Butyloctyl Salicylate, Caprylic/Capric
    Triglyceride, Carthamus tinctorius (Safflower) Seed Oil, Propanediol, Ethyl
    Macadamiate, Methyl Dihydroabietate, Helianthus annuus (Sunflower) Seed Oil,
    Cetearyl Alcohol, Bentonite, Daucus carota sativa (Carrot) Seed Oil, Curcuma
    longa (Turmeric) Root Extract, Boswellia carterii (Frankincense) Oil, Helichrysum
    italicum Flower/Leaf/Stem Oil, Caprylyl Glycol, Coco-Glucoside, Vegetable Oil,
    Microcrystalline Cellulose, Jojoba Esters, Cocos nucifera (Coconut) Fruit Extract,
    Polyhydroxystearic Acid, Bisabolol, Caprylhydroxamic Acid, Sodium Gluconate,
    Tocopherol, Glycerin, Rubus idaeus (Raspberry) Seed Oil, Phytosterols, Cellulose
    Gum, Squalene, Michelia alba (Magnolia) Leaf Oil, Simmondsia chinensis
    (Jojoba) Seed Oil, Cymbopogon flexuosus (Lemongrass) Oil, Aloe barbadensis
    Leaf Juice, Persea gratissima (Avocado) Oil, Cananga odorata (Ylang Ylang) Flower
    Oil, Michelia alba (Magnolia) Flower Oil, Citrus nobilis (Mandarin Orange) Peel Oil

  • Principle Display Panel

    Mineral Sunscreen Spray Broad Spectrum Spray SPF 30

  • Package Label - Direct Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    DOTERRA SUN 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLOCTANOL (UNII: N442D9VO79)  
    SQUALENE (UNII: 7QWM220FJH)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    BENTONITE (UNII: A3N5ZCN45C)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    COCONUT (UNII: 3RT3536DHY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    WATER (UNII: 059QF0KO0R)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    MALIC ACID (UNII: 817L1N4CKP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-173-17170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2022
    Labeler - doTERRA International, LLC (832274935)
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