FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM SPORT 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! Broad Spectrum Sport SPF 50

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

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 or contact a Poison Control Center right away.

Directions

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats, and sunglasses

Other information

Inactive ingredients

water (aqua), C12-15 alkyl benzoate, PEG-8, acrylates/C12-22 alkyl methacrylate copolymer, cetearyl alcohol,
dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl
phosphate (vitamin C), chamomilla recutita (matricaria) flower extract, citrus limon (lemon) peel extract, geranium
maculatum extract, calendula officinalis flower extract, salvia officinalis (sage) leaf extract, arctium lappa root
extract, melissa officinalis leaf extract, propylene glycol, potassium cetyl phosphate, phenoxyethanol,
methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, hydrated silica, acrylates/C10-30
alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

Label

28350E2F2

FRUIT OF THE EARTH BLOCK UP  BROAD SPECTRUM SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-186
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
CHAMOMILE (UNII: FGL3685T2X)  
LEMON PEEL (UNII: 72O054U628)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SAGE (UNII: 065C5D077J)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-186-12237 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/2011
Labeler - FRUIT OF THE EARTH, INC. (079559467)

Revised: 12/2022
Document Id: f04b8e98-9b94-7d07-e053-2995a90a5739
Set id: b3dd42b7-5ee6-4278-863b-88fe7f0be1d5
Version: 3
Effective Time: 20221220
 
FRUIT OF THE EARTH, INC.