FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM SPORT SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Fruit of the Earth Block Up by

Drug Labeling and Warnings

Fruit of the Earth Block Up by is a Otc medication manufactured, distributed, or labeled by FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

ASK DOCTOR

Stop use and ask doctor if rash occurs.

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, 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), chamomilla recutita (matricaria) flower extract, citrus limon (lemon) peel extract, geranium maculatum extract, calendula officianalis 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 Package Display Fruit of the Earth Block Up! Broad Spectrum Sport SPF 50 8 FL OZ (237mL) NDC:

62217-186-12

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH BLOCK UP  BROAD SPECTRUM SPORT SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-186
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CHAMOMILE (UNII: FGL3685T2X)
LEMON PEEL (UNII: 72O054U628)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SAGE (UNII: 065C5D077J)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-186-12	237 mL in 1 TUBE; Type 0: Not a Combination Product	02/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/05/2015

Labeler - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-186)