FRUIT OF THE EARTH BLOCK UP 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 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%, 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

WHEN USING

​When using this product​ keep out of eyes. Rinse with water to remove.

STOP USE

​Stop use and ask doctor if​ rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously and evenly before sun exposure and as needed.
• reapply as needed or after towel drying, swimming, or perspiring.
• children under 6 months of age: ask a doctor

Other information

• may stain some fabrics
• Sun alert: Limiting sun exposure, wearing protective clothing, and

using sunscreen may reduce the risks of aging, skin cancer, and
other harmful effects of the sun.

Inactive ingredients

water (aqua), C12-15 alkyl benzoate, PEG-8,
acrylates/C12-22 alkyl methacrylate copolymer, cetearyl alcohol (and) dicetyl
phosphate (and) ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate
(vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), arnica
montana flower extract (and) chamomilla recutita (matricaria) flower extract (and)
geranium maculatum extract (and) cucumis sativus (cucumber) fruit extract (and)
euphrasia officinalis extract (and) tilia cordata flower extract (and) althaea officinalis
root extract (and) yucca schidigera extract, hydrated silica, potassium cetyl phosphate,
propylene glycol, phenoxyethanol (and) methylparaben (and) propylparaben (and)
butylparaben (and) ethylparaben (and) isobutylparaben, acrylates/C10-30 alkyl acrylate
crosspolymer, disodium EDTA, fragrance (parfum)

Fruit of the Earth, Inc. Block Up! SPF 30 Sunscreen Lotion

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
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

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)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
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)
CUCUMBER (UNII: YY7C30VXJT)
EUPHRASIA STRICTA (UNII: C9642I91WL)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-021-09	88 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/02/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-021)