Otc - Active Ingredient
Active Ingredient Purpose
Zinc Oxide 8.5% ........................Sunscreen
Doterra Sun Lip Balm Mineral Sunscreen Stick
FDA Label NDC 71630-116
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 Lip Balm Mineral Sunscreen (NDC 71630-116). 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 - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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.
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Dosage & Administration
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
Other information • protect this product
from excessive heat and direct sun.
Inactive Ingredient
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
* Please review the disclaimer below.
