FRUIT OF THE EARTH BLOCK UP KIDS SPF 50- 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 Block Up! Kids SPF 50 Lotion

Active ingredients

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

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

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

3250A1

1250A4

FRUIT OF THE EARTH  BLOCK UP KIDS SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HONEY (UNII: Y9H1V576FH)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-005-0988 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2017
2NDC:62217-005-1630 mL in 1 TUBE; Type 0: Not a Combination Product09/29/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/29/2014
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c8230122-05ce-12e8-e053-2a95a90a7d20
Set id: 4bf41c86-0bff-649d-e054-00144ff8d46c
Version: 4
Effective Time: 20210727
 
Fruit of the Earth, Inc.