FRUIT OF THE EARTH SUN TOWN CITY SPF 50 SUNSCREEN- 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 SPF 50 Sunscreen Stick

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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 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

• 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

ozokerite, C12-15 alkyl benzoate, paraffin, adipic acid/diglycol crosspolymer, beeswax, octyldodecyl neopentanoate, dimethicone, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, caprylyl glycol, tocopherol, fragrance.

83669E

83669K

FRUIT OF THE EARTH SUN TOWN CITY SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-076
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) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
WHITE WAX (UNII: 7G1J5DA97F)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-076-851 in 1 BLISTER PACK02/12/2020
1NDC:62217-076-8417 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 finalpart35202/12/2020
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7bc1732-8cdf-9296-e053-2a95a90ac7a3
Set id: c7bbad46-5c52-9f1d-e053-2995a90ae139
Version: 1
Effective Time: 20210722
 
Fruit of the Earth, Inc.