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| Product NDC Code | 71630-116 | ||||
|---|---|---|---|---|---|
| Drug Name | Doterra sun lip balm mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| 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.Active Ingredient Purpose Zinc Oxide 8.5% ........................Sunscreen
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 • use a water resistant sunscreen if swimming or sweating • reapply at least every two 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 Simmondsia chinensis (Jojoba) Seed Oil, Heptyl Undecylenate, Euphorbia cerifera (Candelilla) Wax, Prunus amygdalus dulcis (Sweet Almond) Oil, Jojoba Esters, Persea gratissima (Avocado) Oil, Theobroma cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Rubus idaeus (Raspberry) Seed Oil, 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, Cymbopogon flexuosus (Lemongrass) Oil, Mentha spicata (Spearmint) Leaf/Stem Oil, Leptospermum scoparium (Manuka) Branch/Leaf Oil, Schinziophyton rautanenii (Mongongo) Kernel Oil, Stevia rebaudiana Leaf/Stem Extract, Beta-Sitosterol, Squalene, Carthamus tinctorius (Safflower) Seed Oil, Ricinus communis (Castor) Seed Oil, Aloe barbadensis (Aloe) Extract, Helianthus annuus (Sunflower) Seed Wax, Honey, Tocopherol, Sodium Hyaluronate, 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 Lip Balm Mineral Sunscreen Mineral Sunscreen .BETA.-BISABOLOL PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER ALOE VERA WHOLE CITRUS NOBILIS COCOS NUCIFERA WHOLE LEPTOSPERMUM SCOPARIUM WHOLE BUTYLOCTANOL ALMOND OIL TOCOPHEROL CANDELILLA WAX SODIUM BETA-SITOSTERYL SULFATE HELIANTHUS ANNUUS WHOLE HELIANTHUS ANNUUS SEED WAX CARTHAMUS TINCTORIUS WHOLE BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES AVOCADO OIL RICINUS COMMUNIS SEED MENTHA SPICATA OIL COCOA BUTTER SCHINZIOPHYTON RAUTANENII WHOLE HELICHRYSUM ITALICUM WHOLE SIMMONDSIA CHINENSIS SEED STEVIA REBAUDIANA LEAF BOSWELLIA SERRATA RESIN OIL POTASSIUM HYDROLYZED JOJOBA ESTERS CARROT SEED OIL HONEY CYMBOPOGON FLEXUOSUS WHOLE HEPTYL UNDECYLENATE BUTYLOCTYL SALICYLATE ZINC OXIDE ZINC OXIDE RUBUS IDAEUS SEED SQUALENE
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.Carton Label
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.
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.Directions For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every two hours Children under 6 months of age: ask a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information • protect this product from excessive heat and direct sun.
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