FRUIT OF THE EARTH BLOCK UP KIDS 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 Block Up! 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 • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use • on damaged or broken skin

When using this product

Stop use and ask a doctor if • rash occurs.

Keep out of reach of children. If 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

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, propylene glycol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, hydrastis canadensis (golden seal) root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, hydrated silica, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA

Questions or Comments?

Call toll free 1-800-527-7731

Fruit of the Earth Block Up! Kids SPF 50 Moisturizing Sunscreen Lotion

Representative Image 6oz

Representative Image 8oz

FRUIT OF THE EARTH  BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-013
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)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HONEY (UNII: Y9H1V576FH)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
TILIA CORDATA WHOLE (UNII: W5E5UB44GD)  
COMFREY ROOT (UNII: M9VVZ08EKQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-013-15177 mL in 1 TUBE; Type 0: Not a Combination Product05/23/2017
2NDC:62217-013-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/23/2017
Labeler - Fruit of the Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-013)

Revised: 5/2017
Document Id: 503ab067-0fe8-3d2c-e054-00144ff88e88
Set id: 503a755c-5b86-37d3-e054-00144ff88e88
Version: 1
Effective Time: 20170523
 
Fruit of the Earth, Inc.