FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN- homosalate, octisalate aerosol, spray 
FRUIT OF THE EARTH, INC.

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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FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 8 DRY TANNING OIL SPRAY SUNSCREEN

Active ingredients

Homosalate 7.0%, Octisalate 5.0%

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

FLAMMABLE:

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

Stop use and ask a doctor if

• rash occurs.

Keep out of reach of children.

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

Directions

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

Other information

Inactive ingredients

alcohol denat., mineral oil, tridecyl salicylate, fragrance, acrylates/octylacrylamide copolymer, tocopheryl acetate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil

83241D1

83281D1

FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN 
homosalate, octisalate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
HONEY (UNII: Y9H1V576FH)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-042-37156 g in 1 CAN; Type 0: Not a Combination Product01/15/2019
2NDC:62217-042-7476.5 g in 1 CAN; Type 0: Not a Combination Product04/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/2019
Labeler - FRUIT OF THE EARTH, INC. (079559467)

Revised: 7/2021
Document Id: c792580f-6649-be66-e053-2a95a90a7580
Set id: b6b9c6ff-3d7e-45e8-b764-62667e733905
Version: 2
Effective Time: 20210720
 
FRUIT OF THE EARTH, INC.