FDA.reportPublic FDA data

Bali Body Face and Body Sunscreen Spray SPF50

Manufacturer
Bali Body Pty Ltd
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:51:36

Label at a glance#

ProductBali Body Face and Body Sunscreen SPF 50
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
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

Shake well before use. Hold bottle 4-5 inches away from your body & spray a generous amount to exposed dry skin. 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 su...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 1.8%

Homosalate - 9%

Octisalate - 3%

Octocrylene - 6%

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.

Contents under pressure.

SPL UNCLASSIFIED SECTION

Do not puncture or incinerate. Do not store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use. Hold bottle 4-5 inches away from your body & spray a generous amount to exposed dry skin.
  • 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

Dimethyl Ether, Water, Beeswax, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cocoglycerides, Glycerin, PEG-15 Cocamine, PEG-40 Stearate, Phenoxyethanol, Saccharide Isomerate, Caprylyl Glycol, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Caprylhydroxamic Acid, Tocopheryl Acetate, Aloe Barbadensis Extract, Citric Acid, Sodium Citrate.

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

spf50sprayspf50spray

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70630-002470630-0024-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL ETHERAM13FS69BXIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETYL DIMETHICONE 45IK315POC44IACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
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
SODIUM CITRATE1Q73Q2JULRIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

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
251172c4-3a0d-4c9b-e063-6394a90ad6bfd82cb4de-a9ab-6a8c-e053-2a95a90abc502024-10-22WarningsExact identifier
spl id: 251172c4-3a0d-4c9b-e063-6394a90ad6bf
spl set id: d82cb4de-a9ab-6a8c-e053-2a95a90abc50

Reported adverse events (FAERS/openFDA)#

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