Otc - Active Ingredient
Zinc Oxide 16%
Doterra Sun Lotion
FDA Label NDC 71630-966
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doterra International, Llc for the product Doterra Sun (NDC 71630-966). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - questions, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - Do Not Use
Do not use on damaged or
broken skin.
Otc - 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.
Otc - Purpose
sunscreen
Otc - Questions
Questions or comments? Call 1-800-411-8151
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - 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.
Package Label.Principal Display Panel
Active Ingredient Purpose
Zinc Oxide 16%.................................................................. Sunscreen
* Please review the disclaimer below.
