FRUIT OF THE EARTH, INC. LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN- avobenzone, homosalate, octocrylene 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

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

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, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Xanthan Gum, Disodium EDTA, Hydrogenated Methyl Abiete, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate, Copolymer, Sodium Ascorbyl Phosphate, 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, Polysorbate 20, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Triethanolamine, Propylene Glycol, Hydroxyacetophenone.

PRINCIPAL DISPLAY PANEL

Fruit of the Earth

Luv that Sun

Kids Natural Lotion Sunscreen

Broad Spectrum SPF 50

6.0 FL OZ (177 ML)

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH, INC.  LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN
avobenzone, homosalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCO GLUCOSIDE (UNII: ICS790225B)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
WATERMELON (UNII: 231473QB6R)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
FU LING (UNII: XH37TWY5O4)
APPLE (UNII: B423VGH5S9)
TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-003-15	177 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(62217-003)