FRUIT OF THE EARTH CABANA BEACH CLUBWITH BLOOD ORANGE 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 Blood Orange 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, citrus sinensis (blood orange) oil, citrus aurantium dulcis (orange) peel oil, citrus aurantifolia (lime) oil, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

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FRUIT OF THE EARTH CABANA BEACH CLUBWITH BLOOD ORANGE AND ESSENTIAL OILS SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-061
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)  
ORANGE OIL (UNII: AKN3KSD11B)  
LIME OIL (UNII: UZH29XGA8G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-061-37156 g in 1 CAN; Type 0: Not a Combination Product02/23/2018
2NDC:62217-061-7476.5 g in 1 CAN; Type 0: Not a Combination Product02/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/23/2018
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7803a34-ef9c-2301-e053-2a95a90a4cc7
Set id: c7805f3c-5b95-73bd-e053-2a95a90a9984
Version: 1
Effective Time: 20210719
 
Fruit of the Earth, Inc.