FRUIT OF THE EARTH BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN- avobenzone, 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 30 General Protection Sunscreen Lotion

Active ingredients

Avobenzone 2.0%, 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​ keep out of eyes. Rinse with water to remove.

​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 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

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), 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, propylene glycol, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

Other information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Questions or comments?

Call toll free 1-800-527-7731

Fruit of the Earth Block Up! SPF 30 General Protection Sunscreen Lotion

Representative Image

FRUIT OF THE EARTH  BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-019
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
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)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
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 400 (UNII: B697894SGQ)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
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:62217-019-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/25/2017
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-019)

Revised: 5/2017
Document Id: 505ace8b-823b-098a-e054-00144ff88e88
Set id: 505ace8b-824a-098a-e054-00144ff88e88
Version: 1
Effective Time: 20170525
 
Fruit of the Earth, Inc.