FDA.reportPublic FDA data

Watermelon Tanning Oil SPF15

Manufacturer
Bali Body Pty Ltd
Effective date
2023-08-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:26:48

Label at a glance#

ProductWatermelon Tanning Oil SPF15
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure7 sections

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: Limit...

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octinoxate 5%

Octocrylene 5%.

Purpose:

OTC - PURPOSE SECTION

Sunsreen

Use

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

Grape (Vitis Vinifera) Seed Oil, Sweet Almond (Prunus Dulcis) Oil, Coconut (Cocos Nucifera) Oil, Dicaprylyl Carbonate, Hydrogenated Soy Polyglycerides, Watermelon (Citrullus Lanatus) Seed Oil, Soybean (Glycine Max) Oil, Natural Watermelon Fragrance, C15-23 Alkane, BHT.

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

1515

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-000670630-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GRAPE SEED OIL930MLC8XGGIACT
ALMOND OIL66YXD4DKO9IACT
COCONUT OILQ9L0O73W7LIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
WATERMELON SEED OILL33J06UQTTIACT
SOYBEAN OIL241ATL177AIACT
C15-23 ALKANEJ3N6X3YK96IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
25118634-873d-4cb4-e063-6394a90ac634b044fb45-5c3b-4b80-a60c-e1c44cd268012024-10-22WarningsExact identifier
spl set id: b044fb45-5c3b-4b80-a60c-e1c44cd26801

Reported adverse events (FAERS/openFDA)#

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