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

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

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

Representative Image

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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