FDA.reportPublic FDA data

doTERRA sun Lip Balm Mineral Sunscreen

Manufacturer
doTERRA International, LLC | "Bell International Laboratories "
Effective date
2024-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:47

Label at a glance#

ProductdoTERRA sun Lip Balm Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure11 sections

Storage and handling

Other information • protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information • protect this product
from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonLabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-116-34doTERRA sun Lip Balm Mineral Sunscreen3.5 g in 1 TUBESTICK3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-116DOTERRA SUN LIP BALM MINERAL SUNSCREEN (MINERAL SUNSCREEN) STICK [DOTERRA INTERNATIONAL, LLC]1Current NDC, 1 package rows20240906_20afcd34-efa6-30a7-e063-6394a90ab517.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71630-11671630-116-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-BISABOLOLLP618AV2EAIACT
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER788QAG3W8AIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
CITRUS NOBILIS8MFF77J91VIACT
COCOS NUCIFERA WHOLE245J88W96LIACT
LEPTOSPERMUM SCOPARIUM WHOLEH91OP27WW5IACT
BUTYLOCTANOLN442D9VO79IACT
ALMOND OIL66YXD4DKO9IACT
TOCOPHEROLR0ZB2556P8IACT
CANDELILLA WAXWL0328HX19IACT
SODIUM BETA-SITOSTERYL SULFATEI289C8TPSVIACT
HELIANTHUS ANNUUS WHOLE17S27ZT6KRIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CARTHAMUS TINCTORIUS WHOLE5EMV416J82IACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
AVOCADO OIL6VNO72PFC1IACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
MENTHA SPICATA OILC3M81465G5IACT
COCOA BUTTER512OYT1CRRIACT
SCHINZIOPHYTON RAUTANENII WHOLEQZK412ZY4HIACT
HELICHRYSUM ITALICUM WHOLE391Z7DAJ6VIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
STEVIA REBAUDIANA LEAF6TC6NN0876IACT
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
POTASSIUM HYDROLYZED JOJOBA ESTERSCH428W5O62IACT
CARROT SEED OIL595AO13F11IACT
HONEYY9H1V576FHIACT
CYMBOPOGON FLEXUOSUS WHOLE0MK18YOA5GIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ZINC OXIDESOI2LOH54ZACTIB
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
SQUALENE7QWM220FJHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doTERRA sun Lip Balm Mineral SunscreenMINERAL SUNSCREENdoTERRA International, LLC20afcd34-efa6-30a7-e063-6394a90ab5172024-08-27WarningsExact identifier
ndc (package): 71630-116-34
ndc (product): 71630-116
ndc11 (package): 71630011634
spl id: 20afcd34-efa7-30a7-e063-6394a90ab517
spl set id: 20afcd34-efa6-30a7-e063-6394a90ab517

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.