FRUIT OF THE EARTH BLOCK UP SPF 4 DARK TANNING- 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

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, acrylates/C10-30 alkyl acrylate crosspolymer, daucus carota sativa (carrot) root extract, 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, potassium cetyl phosphate, propylene glycol, hydrated silica, phenoxyethanol (and) methylparaben (and) propylparaben (and) butylparaben (and) ethylparaben (and) isobutylparaben, disodium EDTA, fragrance (parfum)

Fruit of the Earth, Inc. Block Up! SPF 4 Dark Tanning Lotion

INGREDIENTS AND APPEARANCE

FRUIT OF THE EARTH  BLOCK UP SPF 4 DARK TANNING
octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-025
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)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ETHYLPARABEN (UNII: 14255EXE39)
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
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)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-025-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/07/2017

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

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(62217-025)