DOTERRA SUN LIP BALM MINERAL SUNSCREEN- mineral sunscreen stick

doTERRA sun Lip Balm Mineral Sunscreen by

Drug Labeling and Warnings

doTERRA sun Lip Balm Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by doTERRA International, LLC, "Bell International Laboratories ". Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose
Zinc Oxide 8.5% ........................Sunscreen

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.

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

STOP USE

Stop use and ask a doctor if rash occurs

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOTERRA SUN LIP BALM MINERAL SUNSCREEN 
mineral sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71630-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.BETA.-BISABOLOL (UNII: LP618AV2EA)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
CITRUS NOBILIS (UNII: 8MFF77J91V)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
LEPTOSPERMUM SCOPARIUM WHOLE (UNII: H91OP27WW5)
BUTYLOCTANOL (UNII: N442D9VO79)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
CANDELILLA WAX (UNII: WL0328HX19)
SODIUM BETA-SITOSTERYL SULFATE (UNII: I289C8TPSV)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
AVOCADO OIL (UNII: 6VNO72PFC1)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
MENTHA SPICATA OIL (UNII: C3M81465G5)
COCOA BUTTER (UNII: 512OYT1CRR)
SCHINZIOPHYTON RAUTANENII WHOLE (UNII: QZK412ZY4H)
HELICHRYSUM ITALICUM WHOLE (UNII: 391Z7DAJ6V)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
CARROT SEED OIL (UNII: 595AO13F11)
HONEY (UNII: Y9H1V576FH)
CYMBOPOGON FLEXUOSUS WHOLE (UNII: 0MK18YOA5G)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
SQUALENE (UNII: 7QWM220FJH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71630-116-34	3.5 g in 1 TUBE; Type 0: Not a Combination Product	09/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/02/2024

Labeler - doTERRA International, LLC (832274935)

Establishment
Name	Address	ID/FEI	Business Operations
"Bell International Laboratories "		967781555	manufacture(71630-116)