FRUIT OF THE EARTH LIP BALM SPF 30 SUNSCREEN STICK- 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 Sun Town City Lip Balm SPF 30 Sunscreen Stick

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, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol, flavor.

650E1

83771E

83771K

83773E

83772K

FRUIT OF THE EARTH LIP BALM SPF 30 SUNSCREEN STICK 
avobenzone, homosalate, octisalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-078
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
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:62217-078-851 in 1 BLISTER PACK02/13/2020
1NDC:62217-078-8417 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:62217-078-591 in 1 BLISTER PACK04/19/2013
2NDC:62217-078-584.25 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 finalpart35204/19/2013
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c80e0e42-2c71-80ec-e053-2a95a90a80eb
Set id: c80e0e42-2c70-80ec-e053-2a95a90a80eb
Version: 1
Effective Time: 20210726
 
Fruit of the Earth, Inc.