FRUIT OF THE EARTH, INC. ULTRA SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Fruit of the Earth, Inc. by

Drug Labeling and Warnings

Fruit of the Earth, Inc. 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 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

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 a 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

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, aloe barbadensis leaf juice, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, geranium maculatum extract, cucumis sativus (cucmber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis root extract, yucca schidigera leaf/root/stem extract, dicetyl phosphate, tocopherol acetate, sodium ascorbyl phosphate, hydrated silica, potassium cetyl phosphate propylene glycol, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

Questions or comments?

Call toll free 1-800-527-7731

Fruit of the Earth, Inc. Ultra SPF 50 Moisturizing Sunscreen Lotion

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH, INC.  ULTRA SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-006
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CHAMOMILE (UNII: FGL3685T2X)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
CUCUMBER (UNII: YY7C30VXJT)
EUPHRASIA STRICTA (UNII: C9642I91WL)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-006-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/12/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-006)