FRUIT OF THE EARTH SPORT SPF 50 SUNSCREEN CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

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., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

helps prevent sunburn higher SPF gives more sunburn protection

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

Do not use on damaged or broken skin.

WHEN USING

​When using this product keep out of eyes. Rinse with water to remove. keep away from
face to avoid breathing it in. do not puncture or incinerate. Contents under pressure. do not
store at temperatures above 120° F.

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
hold can 4-6 inches away from body, spray evenly to ensure
complete coverage
do not spray into face. Spray into hand and apply to face.
use in well ventilated, but not windy areas
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

alcohol denat. (73.2% v/v), acrylates/octylacrylamide copolymer,
stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate,
tocopherol (vitamin E), ascorbic acid (vitamin C), aloe barbadensis
leaf juice, fragrance (parfum), caprylic/capric triglyceride

Questions or comment?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Sport SPF 50 Sunscreen Continuous Spray

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  SPORT SPF 50 SUNSCREEN CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-012-35	148 mL in 1 CAN; Type 0: Not a Combination Product	05/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/16/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-012)