FDA.reportPublic FDA data

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

Manufacturer
Fruit of the Earth, Inc. | Fruit Of The Earth Research Laboratories, Inc.
Effective date
2017-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:12:35

Label at a glance#

ProductFruit of the Earth SPF 4 Moisturizing Tanning Sunscreen
Active ingredientOCTINOXATE, OXYBENZONE
Label structure13 sections

Indications and uses

• helps prevent sunburn • higher SPF gives more sunburn protection

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.0%, Oxybenzone 0.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

​For external use only

OTC - DO NOT USE SECTION

Do not use • on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

​Stop use and ask doctor if​

  • rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children. ​If product is swallowed, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Representative ImageRepresentative Image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-01162217-011-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
YUCCA SCHIDIGERA08A0YG3VICIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER7K68DGG29PIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
TILIA CORDATA FLOWERCFN6G1F6YKIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARROTL56Z1JK48BIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
EUPHRASIA STRICTAC9642I91WLIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
GERANIUM MACULATUM ROOT93IXI5B6OJIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4d9fa16-1ddd-0324-e053-2a95a90a3b304fa6437a-8aaf-67be-e054-00144ff8d46c2023-02-16WarningsExact identifier
spl set id: 4fa6437a-8aaf-67be-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.