CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion 
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 Sunscreen Lotion

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• 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.,.

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

Other information

Inactive ingredients

Water, Polyester-7, Neopentyl Glycol Diheptanoate, Glycerin, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Citrus sinensis (blood orange) oil, Silica, Phenoxyethanol, Isododecane, Arachidyl Alcohol, Beeswax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG-100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance.

Label

83249E1F1

83245E1F1

CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-245
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
DOCOSANOL (UNII: 9G1OE216XY)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
WHITE WAX (UNII: 7G1J5DA97F)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
HONEY (UNII: Y9H1V576FH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-245-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2018
2NDC:62217-245-4942 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02005/30/2018
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 2/2023
Document Id: f451c472-1da0-1fbc-e053-2995a90a114e
Set id: f451c472-1d9f-1fbc-e053-2995a90a114e
Version: 1
Effective Time: 20230209
 
Fruit of the Earth, Inc.