FRUIT OF THE EARTH, INC. LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN- avobenzone, homosalate, octocrylene lotion 
Fruit of the Earth, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fruit of the Earth, Inc. Luv That Sun Kids SPF 50 Natural Sunscreen Lotion

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

When using this product

Stop use and ask a doctor if

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

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.

Fruit of the Earth

Luv that Sun

Kids Natural Lotion Sunscreen

Broad Spectrum SPF 50

6.0 FL OZ (177 ML)

Label

FRUIT OF THE EARTH, INC.  LUV THAT SUN KIDS SPF 50 NATURAL SUNSCREEN
avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-003-15177 mL in 1 TUBE; Type 0: Not a Combination Product02/06/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/06/2018
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-003)

Revised: 2/2018
Document Id: 6491b1c3-d8f2-a9eb-e053-2a91aa0a11fe
Set id: 6491b1c3-d8f1-a9eb-e053-2a91aa0a11fe
Version: 1
Effective Time: 20180206
 
Fruit of the Earth, Inc.