FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 50- avobenzone, homosalate, octisalate, octocrylene 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 and Essential Oils SPF 50 Continuous Spray

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

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

• limit time in the sun, especially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Inactive ingredients

alcohol denat., isododecane, fragrance, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

82343D1

83283D1

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
ISODODECANE (UNII: A8289P68Y2)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
MINERAL OIL (UNII: T5L8T28FGP)  
PANTHENOL (UNII: WV9CM0O67Z)  
WATER (UNII: 059QF0KO0R)  
HONEY (UNII: Y9H1V576FH)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-063-37156 g in 1 CAN; Type 0: Not a Combination Product05/30/2018
2NDC:62217-063-7476.5 g in 1 CAN; Type 0: Not a Combination Product05/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/30/2018
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7821b2b-f42b-8d08-e053-2a95a90a6bc8
Set id: c7820ba9-7520-5139-e053-2a95a90ab92d
Version: 1
Effective Time: 20210719
 
Fruit of the Earth, Inc.