FRUIT OF THE EARTH BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Fruit of the Earth by

Drug Labeling and Warnings

Fruit of the Earth by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

Do not use on damaged or broken skin

WHEN USING

When using this product

• keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-181(NDC:62217-013)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-181-01	1 in 1 PACKAGE	12/22/2017	05/31/2020
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/22/2017	04/30/2021

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-181) , repack(67751-181)