FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

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

Drug Details [pdf]

Active ingredients

Titanium Dioxide 3.1%, Zinc Oxide 4.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• if rash or irritation develops and last.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply generously and evenly 15 minutes before sun exposure
reapply as needed or:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months: ask a doctor

Other information

• may stain or damage some fabrics, materials or surfaces
• Sun Protection Measures. Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1, Dimethicone, Lauryl PEG-8 Dimethicone, Glycerin, Aloe Barbadensis, Leaf Juice, Sodium Chloride, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Ethylhexyl Methoxycrylene, Dimethicone, Caprylyl Glycol, PEG-8, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Sodium Citrate, Tocopheryl Acetate, Adansonia Digitata Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Hibiscus Sabdariffa Flower Extract, Lens Esculenta (Lentil) Fruit Extract, Phragmites Communis Extract, Polysorbate 20, Pyrus Malus (Apple) Fruit Extract, Poria Cocos Extract, Scutellaria Alpina Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract.

PRINCIPAL DISPLAY PANEL

Fruit of the Earth

Luv that Sun

Natural Mineral Sunscreen Lotion

Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH, INC.  LUV THAT SUN SPF 30 NATURAL MINERAL SUNSCREEN
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40.4625 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31.16 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)
ISOHEXADECANE (UNII: 918X1OUF1E)
SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
FU LING (UNII: XH37TWY5O4)
APPLE (UNII: B423VGH5S9)
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
WATERMELON (UNII: 231473QB6R)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-001-13	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/06/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-001)