FRUIT OF THE EARTH BLOCK UP SPORT SPF 30 SUNSCREEN- avobenzone, 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%, 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 doctor if​

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

​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

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, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E acetate), sodium ascorbyl phosphate (vitamin C phosphate), 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)

Questions or comments?

Call toll free 1-800-527-7731

Principal Display Panel

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  BLOCK UP SPORT SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-182(NDC:62217-009)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
LEMON (UNII: 24RS0A988O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SAGE (UNII: 065C5D077J)
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-182-01	1 in 1 PACKAGE	12/26/2017	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	12/26/2017	05/31/2020

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-182) , repack(67751-182)