FRUIT OF THE EARTH SPF 4 MOISTURIZING TANNING SUNSCREEN- octinoxate, 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

Octinoxate 2.0%, Oxybenzone 0.5%

Purpose

Sunscreen

Uses

helps prevent sunburn higher SPF gives more sunburn protection

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 right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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, aloe barbadensis leaf juice, daucus corota sativa (carrot) root extract, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, germanium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis extract, yucca schidigera extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, potassium cetyl phosphate, propylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, hydrated silica, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, triethanolamine, disodium EDTA, fragrance (parfum)

Questions or comment?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. SPF 4 Moisturizing Tanning Sunscreen Lotion

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  SPF 4 MOISTURIZING TANNING SUNSCREEN
octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
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)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARROT (UNII: L56Z1JK48B)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
EUPHRASIA STRICTA (UNII: C9642I91WL)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-011-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/16/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-011)