FDA.reportPublic FDA data

Bali Body Watermelon Tanning Oil SPF 50

Manufacturer
Bali Body Pty Ltd
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:36

Label at a glance#

ProductBali Body Watermelon Tanning Oil SPF 50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure8 sections

Indications and 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

Dosage and administration

Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply at least every 80 minutes. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin ageing. To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in t...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a poison control centre right away. Store in cool, dark place, Keep out of direct sunlight.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply at least every 80 minutes. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increased your risk of skin cancer and early skin ageing. To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially 10am - 2 pm. Wear a long sleeve shirt, pants, hats and sunglasses. Children under 6 months of age, ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dibutyl Adipate, Dicaprylyl Carbonate, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, VP/Hexadecene Copolymer, Ethylcellulose, Sorbitan Sesquioleate, Tocopherol, Glycerin, Parfum, Citrullus Lanatus Fruit Extract, Aqua, Glycine Soja Oil, Citric Acid.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.
  • Report serious adverse events to AMS Fulfilment 29010 Commerce Centre Drive, Valencia CA 91355

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70630-0036-1Bali Body Watermelon Tanning Oil SPF 50100 mL in 1 BOTTLEOIL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70630-0036BALI BODY WATERMELON TANNING OIL SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [BALI BODY PTY LTD]1Current NDC, 1 package rows20250101_1fd37cec-807e-ddd3-e063-6294a90ae88e.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-003670630-0036-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
OCTISALATE4X49Y0596WACTIB
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
COCONUT OILQ9L0O73W7LIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
WATERMELON231473QB6RIACT
WATER059QF0KO0RIACT
GRAPE SEED OIL930MLC8XGGIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
SOYBEAN OIL241ATL177AIACT
ALMOND OIL66YXD4DKO9IACT
COCO-GLYCERIDESISE9I7DNUGIACT
DIBUTYL ADIPATEF4K100DXP3IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
TOCOPHEROLR0ZB2556P8IACT

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
Bali Body Watermelon Tanning Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd1fd37cec-807e-ddd3-e063-6294a90ae88e2024-08-16WarningsExact identifier
ndc (package): 70630-0036-1
ndc (product): 70630-0036
ndc11 (package): 70630003601
spl id: 1fd37fb2-6866-4827-e063-6394a90ab2c0
spl set id: 1fd37cec-807e-ddd3-e063-6294a90ae88e

Reported adverse events (FAERS/openFDA)#

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