FRUIT OF THE EARTH SUN TOWN CITY- spf 30 lotion sunscreen lotion

Fruit of the Earth by

Drug Labeling and Warnings

Fruit of the Earth 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 8.0%, Octisalate 4.5%, Octocrylene 6.0%

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 casued by the sun

Warnings

For external use only

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep otu of reach of children. If swallowed, get medical help or contact a 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, glycerin, polyester-7, neopentyl glycol diheptanoate, aluminum starch octenylsuccinate, silica, styrene/acrylates copolymer, phenoxyethanol, isododecane, arachidyl alcohol, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance.

Questions of comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Fruit of the Earth Sun Town City SPF 30 Sunscreen Lotion

3.4 FL OZ (100mL)

NDC: 62217-317-82

Fruit of the Earth Sun Town City SPF 30 Sunscreen Lotion

8 FL OZ (237mL)

NDC: 62217-317-11

Fruit of the Earth Sun Town City SPF 30 Sunscreen Lotion

1.5 FL OZ (44mL)

NDC: 62217-317-83

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  SUN TOWN CITY
spf 30 lotion sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-317
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISODODECANE (UNII: A8289P68Y2)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
DOCOSANOL (UNII: 9G1OE216XY)
TOCOPHEROL (UNII: R0ZB2556P8)
YELLOW WAX (UNII: 2ZA36H0S2V)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-317-82	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2020
2	NDC: 62217-317-83	44 mL in 1 TUBE; Type 0: Not a Combination Product	02/13/2020
3	NDC: 62217-317-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/13/2020

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

Registrant - Fruit of the Earth, Inc. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		079559467	manufacture(62217-317)