FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Fruit of the Earth, Inc. by

Drug Labeling and Warnings

Fruit of the Earth, Inc. 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 2.0%

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 a 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

SD Alcohol 40-B, Butyloctyl Salicylate, Acrylates/Octylacrylamide
Copolymer, Hibiscus Sabdariffa Flower Extract, Pyrus Malus (Apple) Fruit
Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta
(Lentil) Fruit Extract, Adansonia Digitata Fruit Extract, Scutellaria Alpina
Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract,
Phragmites Communis Extract, Poria Cocos Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Panthenol, Tocopherol, Fragrance, Diethylhexyl
Syringylidenemalonate, Stearoxytrimethylsilane, Caprylic/Capric
Triglyceride, Water, Glycerin, Polysorbate 20, Phenoxyethanol.

Questions or comments?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Luv That Sun SPF 30 Continuous Spray

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH, INC.  LUV THAT SUN SPF 30 CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-827
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 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

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
FU LING (UNII: XH37TWY5O4)
APPLE (UNII: B423VGH5S9)
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)
ALCOHOL (UNII: 3K9958V90M)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
WATERMELON (UNII: 231473QB6R)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)
SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-827-25	177 mL in 1 CAN; Type 0: Not a Combination Product	05/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/12/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-827)