FDA.reportPublic FDA data

Coconut Lip Balm SPF15

Manufacturer
Bali Body Pty Ltd
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:40

Label at a glance#

ProductCoconut Lip Balm SPF15
Active ingredientOCTISALATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONE
Label structure6 sections

Dosage and administration

Apply to clean lips for long lasting hydration and a dewy glow

Label contents#

Full prescribing information#

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to clean lips for long lasting hydration and a dewy glow

Warnings:

WARNINGS SECTION

For external use only. Keep out of direct sunlight or other sources of strong light. Product to be stored beteen 5-28°C. Discontinues use if irritation occurs. Subtle variations in appearance and texture of this product in no way affect its integrity.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please refer to balibodyco.com for further sun-safety instructions.

Use:

INDICATIONS & USAGE SECTION

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octisalate 2.8%
Homosalate 2.8%
Octocrylene 2.8%
Avobenzone 2%

Purpose:

OTC - PURPOSE SECTION

Sunsreen

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Ricinus Communis (Castor) Seed Oil, Hydrogenated Soybean Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Euphorbia Cerifera (candelilla) Wax, Water (Aqua), Simmondsia Chinesis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vanilla Planifolia Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Daucus Carota Sativa (Carrot) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Xanthan Gum, Flavor (Aroma), Stevioside, Polyglyceryl-3 Diisostearate, Potassium Sorbate, Citric Acid, Sodium Hydroxide, Alcohol, Annatto(CI 75120)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-001470630-0014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
COCONUT OILQ9L0O73W7LIACT
COCOA BUTTER512OYT1CRRIACT
CANDELILLA WAXWL0328HX19IACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
SOYBEAN OIL241ATL177AIACT
VANILLA PLANIFOLIA OIL0A3F415158IACT
SUNFLOWER OIL3W1JG795YIIACT
DAUCUS CAROTA SUBSP. SATIVUS SEED9M6AAX381UIACT
CHAMOMILEFGL3685T2XIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
STEVIOSIDE0YON5MXJ9PIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
ANNATTO6PQP1V1B6OIACT
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

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
ec92a1e6-be35-6eb8-e053-2995a90a1d859b8cce1d-cfbd-4ca7-a59e-c3609d4da26c2022-11-03WarningsExact identifier
spl set id: 9b8cce1d-cfbd-4ca7-a59e-c3609d4da26c

Reported adverse events (FAERS/openFDA)#

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