FDA.reportPublic FDA data

Bali Body Hydrating Body Sunscreen SPF50

Manufacturer
Bali Body Pty Ltd
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:28:06

Label at a glance#

ProductBali Body Hydrating Body Sunscreen SPF50
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE
Label structure9 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

Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 80 minutes Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 3.00% w/w

Homosalate - 15.00% w/w

Octisalate - 5.00% w/w

Octocrylene - 10.00% w/w

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 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 80 minutes
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Beeswax, Cocoglycerides, Cetyl Dimethicone, Silica, PEG-15 Cocamine, Glycerin, C12-15 Alkyl Benzoate, PEG-40 Stearate, Tocopheryl Acetate, Phenoxyethanol, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Caprylhydroxamic Acid, Aloe Barbadensis Extract.

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, 19355

Company Information

SPL UNCLASSIFIED SECTION

Dist. by Bali Body Pty Ltd

428 New Street

Brighton 3186, Australia

balibodyco.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

spf50 bodyspf50 body

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70630-0025BALI BODY HYDRATING BODY SUNSCREEN SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [BALI BODY PTY LTD]3Legacy NDC20241023_d8dafe75-2cda-b8b3-e053-2995a90a1ef5.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
70630-002570630-0025-1

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
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETYL DIMETHICONE 45IK315POC44IACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
YELLOW WAX2ZA36H0S2VIACT
PEG-15 COCAMINE8L6LB12TSJIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCO-GLYCERIDESISE9I7DNUGIACT
PEG-40 STEARATEECU18C66Q7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROLAMINE9O3K93S3TKIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
HOMOSALATEV06SV4M95SACTIB
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
415136e0-84c7-22d9-e063-6394a90a212ad8dafe75-2cda-b8b3-e053-2995a90a1ef52025-10-16WarningsExact identifier
spl set id: d8dafe75-2cda-b8b3-e053-2995a90a1ef5

Reported adverse events (FAERS/openFDA)#

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