FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 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.

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Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 Lotion Sunscreen

Active ingredients

Titanium Dioxide 3.0%

Zinc Oxide 15.0%

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, caprylic/capric triglyceride, neopentyl glycol diheptanoate, butyloctyl salicylate, glycerin, olive oil polyglyceryl-6 pentaloeate, stearly/octldodecyl citrate crosspolymer, VP/hexadecene copolymer, glyceryl stearate, magnesium sulfate, silica, simmondsia chinensis (jojoba) seed oil, ethylhexylglycerin, aloe barbadensis leaf juice, avena sativa (oat) kernel extract, tocopherol, sodium hydroxide

Label

83678EF

83679EF

FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-241
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 CATION150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-241-13100 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/08/2022
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 2/2023
 
Fruit Of The Earth, Inc.