BALI BODY HYDRATING BODY SUNSCREEN SPF50- avobenzone, homosalate, octisalate, octocrylene lotion 
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 Hydrating Body Sunscreen SPF50

Drug Facts

Active ingredients

Avobenzone - 3.00% w/w

Homosalate - 15.00% w/w

Octisalate - 5.00% w/w

Octocrylene - 10.00% w/w

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.

Directions

Inactive ingredients

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

Company Information

Dist. by Bali Body Pty Ltd

428 New Street

Brighton 3186, Australia

balibodyco.com

Product Packaging

spf50 body

BALI BODY HYDRATING BODY SUNSCREEN SPF50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70630-0025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
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)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70630-0025-11 in 1 BOX02/25/2022
1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/25/2022
Labeler - Bali Body Pty Ltd (757840223)

Revised: 2/2022
Document Id: d8dc40f3-c35e-30c3-e053-2995a90a155a
Set id: d8dafe75-2cda-b8b3-e053-2995a90a1ef5
Version: 2
Effective Time: 20220225
 
Bali Body Pty Ltd