FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 SUNSCREEN- titanium dioxide, zinc oxide spray 
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 Sunscreen Spray

Active ingredients

Titanium Dioxide 3.5%

Zinc Oxide 7.25%

Purpose

Sunscreen

Uses

Warnings

​For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

​Do not use

When using this product

• keep out of eyes. Rinse with water to remove.

• keep away from to avoid breathing it.

• do not puncture or incinerate. Contents under pressure.

• do not store at temperatures above 120° F.

Stop use and ask doctor if​

Keep out of reach of children. ​

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

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold can 4-6 inches away from skin top apply
• do not spray into face. Spray into hand and apply to face.
• use in a well ventilated areas

reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

• children under 6 months: 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 the container from excessive heat and direct sun
• may stain or damage some fabrics

Inactive ingredients

Water, Isohexadecane, Isododecane, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Shea Butter Ethyl Esters, Carthamus Tinctorius (Safflower) Seed Oil, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Butyloctyl Salicylate, Coco-Glucoside, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Sorbitan Olivate, Ethylhexylglycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Leaf Juice, Tocopherol, Glycerin, Sodium Gluconate, Citric Acid.

Label

83680D

83681D

FRUIT OF THE EARTH SUN TOWN CITY BABY AND KIDS MINERAL SPF 50 SUNSCREEN 
titanium dioxide, zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE72.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISODODECANE (UNII: A8289P68Y2)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
COCO GLUCOSIDE (UNII: ICS790225B)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-242-0888 g in 1 CAN; Type 0: Not a Combination Product02/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/07/2022
Labeler - Fruit Of The Earth, Inc. (079559467)

Revised: 2/2023
Document Id: f42a0b1e-038e-4fab-e053-2995a90a5364
Set id: f42a0b1e-038d-4fab-e053-2995a90a5364
Version: 1
Effective Time: 20230207
 
Fruit Of The Earth, Inc.