FRUIT OF THE EARTH SUN TOWN CITY KIDS SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen by

Drug Labeling and Warnings

Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

Sunscreen

Uses

helps prevent sunburn if used as directed with other sun protectino measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove keep away from face to avoid breathing it. do not puncture or incerate. Contents under pressures. do not store at temperatures above 120°F.

Stop use and ask a doctor if

if rash occurs.

Keep out of reach of children.

If 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 the skin to apply
• Do not spray directly into face. Spray into hands then apply to face
• Do not apply in windy conditions
• Use in a well-ventilated area.
• 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 othe rsun 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

alcohol denat., isododecane, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract, fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH SUN TOWN CITY KIDS SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ISODODECANE (UNII: A8289P68Y2)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-067-37	156 g in 1 CAN; Type 0: Not a Combination Product	11/26/2019
2	NDC: 62217-067-74	76.5 g in 1 CAN; Type 0: Not a Combination Product	11/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/26/2019

Labeler - Fruit of the Earth, Inc. (079559467)