FRUIT OF THE EARTH BLOCK UP SPF 70 GENERAL PROTECTION SUNSCREEN- avobenzone, homosalate, 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 Fruit of the Earth, Inc., Fruit Of The Earth Research Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

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

Inactive ingredients

water, butylene glycol, microcrystalline cellulose, glyceryl stearate, behenyl alcohol, benzyl alcohol, diethylhexyl syringylidene malonate, aloe barbadensis leaf juice, tocopherol (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, stearic acid, palmitic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, lecithin, caprylic/capric triglyceride, chlorphenesin, cellulose gum, butylated PVP, N-vinylpyrrolidone, 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 70 General Protection Sunscreen Lotion

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  BLOCK UP SPF 70 GENERAL PROTECTION SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
STEARIC ACID (UNII: 4ELV7Z65AP)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
PALMITIC ACID (UNII: 2V16EO95H1)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CUCUMBER (UNII: YY7C30VXJT)
EUPHRASIA STRICTA (UNII: C9642I91WL)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-020-22	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/07/2018

Labeler - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-020)