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| Product NDC Code | 71630-966 | ||||
|---|---|---|---|---|---|
| Drug Name | Doterra sun |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | doTERRA International, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 16%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.doTERRA Sun Zinc Oxide COCONUT OIL CAPRYLHYDROXAMIC ACID EAST INDIAN LEMONGRASS OIL ISOAMYL LAURATE AVOCADO OIL BUTYLOCTYL SALICYLATE HELICHRYSUM ITALICUM FLOWER OIL ZINC OXIDE ZINC OXIDE ALOE VERA LEAF CARROT SEED OIL SODIUM BENZOATE LAURYL LAURATE POLYGLYCERYL-2 ISOSTEARATE SODIUM CHLORIDE YLANG-YLANG OIL METHYL DIHYDROABIETATE ASTROCARYUM MURUMURU SEED BUTTER POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM GLUCONATE TOCOPHEROL RASPBERRY SEED OIL SUNFLOWER OIL MANDARIN OIL MICHELIA ALBA LEAF OIL SQUALENE POLYGLYCERYL-6 POLYRICINOLEATE PROPANEDIOL CETYL ALCOHOL XANTHAN GUM BUTYLOCTANOL DISTEARDIMONIUM HECTORITE FRANKINCENSE OIL POTASSIUM SORBATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Active Ingredient Purpose Zinc Oxide 16%.................................................................. Sunscreen Face and Body Lotion Direct Tube Face and Body Lotion Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-411-8151
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API