FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 30 SUNSCREEN- titanium dioxide, 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.

----------

Fruit of the Earth Sun Town City Mineral SPF 30 Lotion Sunscreen

Active ingredients

Titanium Dioxide 3.0%

Zinc Oxide 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, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sorbitan tristearate, silica, stearyl/octldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, aloe barbadensis leaf juice, glycerine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid, fragrance.

Label

83675EF

83677F1

FRUIT OF THE EARTH SUN TOWN CITY MINERAL SPF 30 SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-243
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DOCOSANOL (UNII: 9G1OE216XY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
OAT (UNII: Z6J799EAJK)  
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
SOYBEAN (UNII: L7HT8F1ZOD)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-243-13100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/11/2021
2NDC:62217-243-4942 mL in 1 BOTTLE; Type 0: Not a Combination Product09/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/29/2021
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 2/2023
Document Id: f4481bfc-a1b4-30f0-e053-2a95a90a7223
Set id: f4481bf3-6dc7-5641-e053-2a95a90ad938
Version: 1
Effective Time: 20230209
 
Fruit Of The Earth, Inc.