FRUIT OF THE EARTH BLOCK UP 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! 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 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 liberally 15 minutes before sun exposure

• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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 value 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Other information

• protect the product in this container 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, propylene glycol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), arnica montana flower extract, chamomilla recutita (matricaria) flower extract, geranium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis root extract, yucca schidigera extract, hydrated silica, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, fragrance (parfum)

1050A3

3050A2

FRUIT OF THE EARTH  BLOCK UP SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-050
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
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)  
CHAMOMILE (UNII: FGL3685T2X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CUCUMBER (UNII: YY7C30VXJT)  
EUPHRASIA STRICTA (UNII: C9642I91WL)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-050-1630 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2013
2NDC:62217-050-0388 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/19/2013
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 7/2021
Document Id: c836a43e-35e6-ed91-e053-2995a90a3ce1
Set id: 4b3fd666-4152-47c8-e054-00144ff8d46c
Version: 4
Effective Time: 20210728
 
Fruit of the Earth, Inc.