FRUIT OF THE EARTH SUN TOWN CITY SPF 50 ZINC SUNSCREEN- octocrylene, zinc oxide 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 Sun Town City SPF 50 Zinc Sunscreen

Active ingredients

Zinc Oxide 5.0%, Octocrylene 4.0%

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

water, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, hydrogenated castor oil, polyglyceryl-4 isostearate, hexyl laurate, beeswax, isohexadecane, phenoxyethanol, silica, ethylhexylglycerin, triethoxycaprylylsilane, dimethicone, sodium chloride, disodium EDTA, aloe barbadensis leaf powder, sodium ascorbyl phosphate, tocopherol, fragrance.

83770TEK

FRUIT OF THE EARTH SUN TOWN CITY SPF 50 ZINC SUNSCREEN 
octocrylene, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-075-431 in 1 CARTON01/20/2020
1NDC:62217-075-4229.6 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/20/2020
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7bab82d-a817-5154-e053-2995a90a8e47
Set id: c7bab82d-a816-5154-e053-2995a90a8e47
Version: 1
Effective Time: 20210722
 
Fruit of the Earth, Inc.