BALI BODY FACE AND BODY SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene aerosol 
Bali Body Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bali Body Face and Body Sunscreen Spray SPF50

Drug Facts

Active ingredients

Avobenzone - 1.8%

Homosalate - 9%

Octisalate - 3%

Octocrylene - 6%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Contents under pressure.

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

Inactive ingredients

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

Company Information

Dist. by Bali Body Pty Ltd

428 New Street

Brighton 3186, Australia

balibodyco.com

Product Packaging

spf50spray

BALI BODY FACE AND BODY SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHYL ETHER (UNII: AM13FS69BX)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0024-11 in 1 BOX02/22/2022
1175 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/22/2022
Labeler - Bali Body Pty Ltd (757840223)

Revised: 2/2022
Document Id: d82cb4de-a9ac-6a8c-e053-2a95a90abc50
Set id: d82cb4de-a9ab-6a8c-e053-2a95a90abc50
Version: 1
Effective Time: 20220216
 
Bali Body Pty Ltd