FDA.reportPublic FDA data

Bali Body Watermelon Tanning Oil SPF 15

Manufacturer
Bali Body Pty Ltd
Effective date
2024-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:33:34

Label at a glance#

ProductBali Body Watermelon Tanning Oil SPF 15
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure7 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 ageing caused by the sun

Dosage and administration

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear a water resistant sunscreen if swimming or sweating. Sun Protection Measures . 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: Limi...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 9%

Octisalate 5%

Avobenzone 3%

Purpose:

OTC - PURPOSE SECTION

Sunsreen

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 ageing 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

If product is swallowed, get medical help or contact a poison control centre right away.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 hours. Wear a water resistant sunscreen if swimming or sweating. Sun Protection Measures. 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 ingredients

INACTIVE INGREDIENT SECTION

Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Prunus Amygdalus Dulcis Oil, Cocoglycerides, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Citrullus Lanatus Seed Oil, Ethylcellulose, Tocopherol, Parfum, Glycine Soja Oil, Benzyl Alcohol, Citronellol, Rose Ketone-4, Geranol, Linalool, Benzyl Benzoate, Benzyl Salicylate, Cinnamyl Alcohol.

Other information

OTHER SAFETY INFORMATION

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

Package Labeling

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70630-0035-1Bali Body Watermelon Tanning Oil SPF 15100 mL in 1 BOTTLEOIL1002
70630-0035-2Bali Body Watermelon Tanning Oil SPF 1520 mL in 1 BOTTLEOIL202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70630-0035BALI BODY WATERMELON TANNING OIL SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) OIL [BALI BODY PTY LTD]2Current NDC, 2 package rows20241105_07d96576-fd78-acf3-e063-6394a90af45b.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-003570630-0035-1, 70630-0035-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
BENZYL ALCOHOLLKG8494WBHIACT
GERANIOLL837108USYIACT
LINALOOL, (+/-)-D81QY6I88EIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
BENZYL BENZOATEN863NB338GIACT
SOYBEAN OIL241ATL177AIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
CINNAMYL ALCOHOLSS8YOP444FIACT
TOCOPHEROLR0ZB2556P8IACT
ALMOND OIL66YXD4DKO9IACT
COCONUT OILQ9L0O73W7LIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
WATERMELON SEED OILL33J06UQTTIACT
COCO-GLYCERIDESISE9I7DNUGIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
GRAPE SEED OIL930MLC8XGGIACT

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 15AVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd07d96576-fd78-acf3-e063-6394a90af45b2024-11-03WarningsExact identifier
ndc (package): 70630-0035-1
ndc (package): 70630-0035-2
ndc (product): 70630-0035
ndc11 (package): 70630003502
ndc11 (package): 70630003501
spl id: 260a6a86-5a11-15e8-e063-6294a90a770b
spl set id: 07d96576-fd78-acf3-e063-6394a90af45b

Reported adverse events (FAERS/openFDA)#

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