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.

Fruit of the Earth

Luv that Sun

Natural Mineral Sunscreen Lotion

Broad Spectrum SPF 30

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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

Fruit of the Earth, Inc. Luv That Sun SPF 30 Natural Mineral Sunscreen Lotion