DOTERRA SUN- zinc oxide lotion

doTERRA Sun by

Drug Labeling and Warnings

doTERRA Sun 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

Zinc Oxide 16%

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.

DO NOT USE

Do not use on damaged or
broken skin.

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.

PURPOSE

sunscreen

QUESTIONS

Questions or comments? Call 1-800-411-8151

STOP USE

Stop use and ask a doctor if rash occurs.

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.

PRINCIPAL DISPLAY PANEL

Active Ingredient Purpose
Zinc Oxide 16%.................................................................. Sunscreen

INGREDIENTS AND APPEARANCE

DOTERRA SUN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71630-966
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
AVOCADO OIL (UNII: 6VNO72PFC1)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARROT SEED OIL (UNII: 595AO13F11)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LAURYL LAURATE (UNII: GPW77G0937)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
YLANG-YLANG OIL (UNII: 8YOY78GNNX)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
TOCOPHEROL (UNII: R0ZB2556P8)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MANDARIN OIL (UNII: NJO720F72R)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
SQUALENE (UNII: 7QWM220FJH)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLOCTANOL (UNII: N442D9VO79)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71630-966-50	142 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2022

Labeler - doTERRA International, LLC (832274935)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(71630-966)