FRUIT OF THE EARTH BLOCK UP LITE BROAD SPECTRUM SPF 30 CONTINUOUS SUNSCREEN- avobenzone, homosalate, octisalate, 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.0%, Homosalate 15.0%, Octisalate 5.0%, Oxybenzone 4.0%

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 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

Do not use on damaged or broken skin.

WHEN USING

​When using this product keep out of eyes. Rinse with water to remove. 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 or contact a Poison Control Center 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. (76.16% v/v), acrylates/octylacrylamide copolymer, glycerin, aloe barbadensis leaf juice, tocopherol (vitamin E), fragrance, ascorbic acid (vitamin C)

Questions or comment?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Block Up! Lite Broad Spectrum SPF 30 Continuous Sunscreen Spray

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  BLOCK UP LITE BROAD SPECTRUM SPF 30 CONTINUOUS SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-027
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	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 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)
ALCOHOL (UNII: 3K9958V90M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-027-25	177 mL in 1 CAN; Type 0: Not a Combination Product	06/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/09/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-027)