FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING SPF 8 SUNSCREEN- avobenzone, 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 Sun Town City Dark Tanning SPF 8 Lotion Sunscreen

Active ingredients

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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, octyldodecyl neopentanoate, glycerin, butyloctyl salicylate, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, triethanolamine, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal.

83650EF

FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING SPF 8 SUNSCREEN 
avobenzone, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-072-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/09/2019
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c7aa1e58-f7b4-6b7f-e053-2995a90a957c
Set id: c7aa1e58-f7b3-6b7f-e053-2995a90a957c
Version: 1
Effective Time: 20210721
 
Fruit of the Earth, Inc.