FRUIT OF THE EARTH CABANA BEACH CLUB LIP BALM WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 30- avobenzone, homosalate, octisalate, octocrylene stick 
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 Lip Balm with Blood Orange and Essential Oils SPF 30

Active ingredients

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

Purpose

Sunscreen

Uses

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

• 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

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, aloe barbadensis leaf juice, mineral oil, ascorbyl palmitate, citrus sinensis (blood orange) oil, citrus aurantium dulcis (orange) peel oil, aurantifolia (lime) oil, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol, fragrance.

83257E1

83257K

FRUIT OF THE EARTH CABANA BEACH CLUB LIP BALM WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 30 
avobenzone, homosalate, octisalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
LIME OIL (UNII: UZH29XGA8G)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PARAFFIN (UNII: I9O0E3H2ZE)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CANDELILLA WAX (UNII: WL0328HX19)  
CERESIN (UNII: Q1LS2UJO3A)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-082-591 in 1 BLISTER PACK05/30/2018
1NDC:62217-082-584.25 g in 1 CONTAINER; Type 0: Not a Combination Product
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: 8/2021
Document Id: c9645b41-2cee-5feb-e053-2a95a90ab969
Set id: c9645bf0-87ba-6eec-e053-2995a90a09b8
Version: 1
Effective Time: 20210812
 
Fruit of the Earth, Inc.