FRUIT OF THE EARTH SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone 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. Kids SPF 50 Moisturizing Sunscreen Lotion

Active ingredients

Avobenzone 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn • higher SPF gives more sunburn protection

Warnings

​For external use only

Do not use • on damaged or broken skin.

​When using this product​ keep out of eyes. Rinse with water to remove.

​Stop use and ask doctor if

  • rash occurs.

​Keep out of reach of children. ​If product is swallowed, get medical help right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: ask a doctor
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

water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, hydrated silica, potassium cetyl phosphate, propylene glycol, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene
glycol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA

Questions or comment?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Kids SPF 50 Moisturizing Sunscreen Lotion

Representative Image

FRUIT OF THE EARTH  SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HONEY (UNII: Y9H1V576FH)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-008-0388 mL in 1 TUBE; Type 0: Not a Combination Product05/16/201705/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/16/201705/16/2017
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-008)

Revised: 7/2021
 
Fruit of the Earth, Inc.