Label: DOTERRA SUN- zinc oxide lotion

  • NDC Code(s): 71630-966-50
  • Packager: doTERRA International, LLC
  • 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 April 21, 2022

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

View All Sections
  • ACTIVE INGREDIENT

    Zinc Oxide 16%

  • ASK DOCTOR

    Children under 6 months of age: Ask a doctor

    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.

  • DO NOT USE

    Do not use on damaged or
    broken skin.

  • 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.

  • PURPOSE

    sunscreen

  • QUESTIONS

    Questions or comments? Call 1-800-411-8151

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • WHEN USING

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

    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

  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua), Isoamyl Laurate, Persea
    gratissima (Avocado) Oil, Calcium Sodium Borosilicate, Butyloctyl
    Salicylate, Polyglyceryl-6 Polyricinoleate, Lauryl Laurate, C18-21
    Alkane, Methyl Dihydroabietate, Propanediol, Polyglyceryl-2
    Isostearate, Cetyl Alcohol, Sodium Chloride, Silica Silylate, Daucus
    carota sativa (Carrot) Seed Oil, Boswellia carterii (Frankincense) Oil,
    Helichrysum italicum Flower/Leaf/Stem Oil, Disteardimonium
    Hectorite, Astrocaryum tucuma Seed Butter, Rubus idaeus
    (Raspberry) Seed Oil, Xanthan Gum, Helianthus annuus (Sunflower)
    Seed Oil, Cocos nucifera (Coconut) Fruit Extract, Polyhydroxystearic
    Acid, Sodium Gluconate, Caprylhydroxamic Acid, Tocopherol,
    Phytosterols, Michelia alba (Magnolia) Leaf Oil, Squalene,
    Cymbopogon flexuosus (Lemongrass) Oil, Cananga odorata (Ylang
    Ylang) Flower Oil, Aloe barbadensis Leaf Juice, Michelia alba
    (Magnolia) Flower Oil, Citrus nobilis (Mandarin Orange) Peel Oil

  • OTHER SAFETY INFORMATION

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

  • DOSAGE & ADMINISTRATION

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

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Face and Body Lotion Direct TubeActive Ingredient Purpose
    Zinc Oxide 16%.................................................................. Sunscreen Face and Body Lotion Carton

  • INGREDIENTS AND APPEARANCE
    DOTERRA SUN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-966
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    YLANG-YLANG OIL (UNII: 8YOY78GNNX)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MANDARIN OIL (UNII: NJO720F72R)  
    MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)  
    SQUALENE (UNII: 7QWM220FJH)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLOCTANOL (UNII: N442D9VO79)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-966-50142 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 finalpart35206/01/2022
    Labeler - doTERRA International, LLC (832274935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(71630-966)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!