FRUIT OF THE EARTH SPORT SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone 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 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

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.

STOP USE

​Stop use and ask doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If product is swallowed, get medical help 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

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 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: ask a doctor

Other information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, anthemis nobilis flower extract, citrus limon (lemon) peel extract, geranium maculatum extract, calendula officinalis flower extract, salvia officinalis (sage) leaf extract, arctium lappa root extract, melissa officinalis leaf extract, juglans nigra (black walnut) leaf extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, propylene glycol, potassium cetyl phosphate, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Fruit of the Earth Sport SPF 50

Moisturizing Lotion Sunscreen

BROAD SPECTRUM SPF 50

WITH ALOE VERA

water resistant (80 minutes)

paraben free

dermatologist tested

1 FL OZ (30mL)

NDC: 62217-350-16

Fruit of the Earth Sport SPF 50

Moisturizing Lotion Sunscreen

BROAD SPECTRUM SPF 50

WITH ALOE VERA

water resistant (80 minutes)

paraben free

dermatologist tested

3 FL OZ (88mL)

NDC: 62217-350-09

Fruit of the Earth Sport SPF 50

Moisturizing Lotion Sunscreen

BROAD SPECTRUM SPF 50

WITH ALOE VERA

water resistant (80 minutes)

paraben free

dermatologist tested

8 FL OZ (237mL)

NDC: 62217-350-11

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
LEMON PEEL (UNII: 72O054U628)
SAGE (UNII: 065C5D077J)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-350-16	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/21/2017
2	NDC: 62217-350-09	88 mL in 1 TUBE; Type 0: Not a Combination Product	03/21/2017
3	NDC: 62217-350-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/21/2017

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

Registrant - Fruit Of The Earth Research Laboratories, Inc. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit of the Earth, Inc.		079559467	manufacture(62217-350)