HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50- homosalate, octocrylene, octisalate, avobenzone cream 
Baxter Laboratories 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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Hydrating Body Sunscreen UVA and UVB Broad Spectrum SPF50

Active ingredients Purpose

Homosalate 10% .............Sunscreen

Octocrylene 8% ...............Sunscreen

Octisalate 5% ..................Sunscreen

Avobenzone 3% ..............Sunscreen

Uses

Keep our of reach of children.

Stop use and ask a doctor if rash occurs

Warnings

Directions

Inactive ingredients

Water, Beeswax, Isopropryl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinensis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric Acid

Other informaiton Protect the product in this container from excessive heat and direct sun

Questions or comments?
Contact us at frankbody.com

frank body

SPF 50+

Hydrating Body Sunscreen

UVA + UVB Broad Spectrum SPF50+

With hyaluronic acid

Fast absorbing

Water resistant (80 minutes)

4.73fl oz - 140ml

SPF 50 hydrating label

HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50 
homosalate, octocrylene, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70157-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TROLAMINE (UNII: 9O3K93S3TK)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
JOJOBA OIL (UNII: 724GKU717M)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70157-009-01140 mL in 1 BOTTLE; Type 0: Not a Combination Product12/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02012/01/2022
Labeler - Baxter Laboratories Pty. Ltd. (740537709)

Revised: 11/2022
Document Id: eea4461d-3ccc-a410-e053-2995a90a5558
Set id: eea4461d-3ccb-a410-e053-2995a90a5558
Version: 1
Effective Time: 20221129
 
Baxter Laboratories Pty. Ltd.