FRUIT OF THE EARTH CABANA BEACH CLUB WITH MENTHA 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 Mentha 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, mentha viridis (spearmint) leaf oil, santalum spicatum seed oil (sandalwood), citrus aurantium dulcis (orange) flower oil, ascorbly palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

83263D1

83293D1

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MENTHA AND ESSENTIAL OILS SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-064
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SPEARMINT OIL (UNII: C3M81465G5)  
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-064-37156 g in 1 CAN; Type 0: Not a Combination Product05/30/2018
2NDC:62217-064-7476.5 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: c7900332-27a9-0c05-e053-2a95a90a44f1
Set id: c790031d-5448-a998-e053-2a95a90a763e
Version: 1
Effective Time: 20210720
 
Fruit of the Earth, Inc.