FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN- avobenzone, homosalate, 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.

----------

Fruit of the Earth Sun Town City Mineral SPF 70 Lotion Sunscreen

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 product is swallowed, get medical help or contact a Poison Control Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

Water, Shea Butter Ethyl Esters, Isodecyl Neopentanoate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Cetearyl Olivate, PEG-100 Stearate, Diisopropyl Sebacate, Lauryl Lactate, Sorbitan Olivate, Silica, Glyceryl Caprylate, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Phenethyl Alcohol, Glycerin, Xanthan Gum, Ethylhexylglycerin, Tetrasodium EDTA, Sodium Hydroxide, Fragrance.

Label

83700E1F1

83701EF

FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 70 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-250-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/11/2021
2NDC:62217-250-13100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02010/11/2021
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 2/2023
Document Id: f5402884-0eb4-342b-e053-2995a90a10e5
Set id: f53fff7a-ef8b-19c4-e053-2a95a90a4a2a
Version: 1
Effective Time: 20230221
 
Fruit Of The Earth, Inc.