FDA.reportPublic FDA data

Fruit of the Earth

Manufacturer
Fruit of the Earth, Inc.
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:27:28

Label at a glance#

ProductFruit of the Earth Sun Town City
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure13 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging casued by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply:    • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours Children under 6 months of age: Ask a doctor 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 value of 15 or higher a...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn • if used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging casued by the sun

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 - ASK DOCTOR SECTION

Stop use and ask a doctor if • rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply:

   • after 80 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

  • Children under 6 months of age: Ask a doctor
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, aloe barbadensis leaf juice, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol, flavor.

Questions of comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-527-7731

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

0.65 OZ (17g)

NDC 62217-316-84

NDC 62217-316-85

LabelLabelLabel blisterFrontLabel blisterFrontLabel blisterBackLabel blisterBack

Fruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

0.15 OZ (4.25g)

NDC 62217-316-58

NDC 62217-316-59

LabelLabel

Label blisterLabel blister

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62217-316-592021-07-23C16284748780-1c7ccaba7-282c-fd44-e053-dadaa90aa01bFruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick
62217-316-852021-07-23C16284748780-1c7ccaba7-282c-fd44-e053-dadaa90aa01bFruit of the Earth Sun Town City Lip Balm SPF 30 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-316-58Fruit of the EarthSun Town City4.25 g in 1 CONTAINERSTICK4.253
62217-316-59Fruit of the EarthSun Town City1 in 1 BLISTER PACKSTICK13
62217-316-84Fruit of the EarthSun Town City17 g in 1 CONTAINERSTICK173
62217-316-85Fruit of the EarthSun Town City1 in 1 BLISTER PACKSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-316FRUIT OF THE EARTH SUN TOWN CITY (LIP BALM SPF 30 SUNSCREEN STICK) STICK [FRUIT OF THE EARTH, INC.]3Current NDC, Legacy NDC, 4 package rows20241020_3ec16996-ae86-4f5b-b1fd-c7b509cc5d50.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-31662217-316-84, 62217-316-85, 62217-316-58, 62217-316-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PARAFFINI9O0E3H2ZEIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CANDELILLA WAXWL0328HX19IACT
CERESINQ1LS2UJO3AIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
ASCORBYL PALMITATEQN83US2B0NIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE92RU3N3Y1OIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB

Source Document#

Source XML

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
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
ndc (package): 62217-316-59
ndc (package): 62217-316-58
ndc (package): 62217-316-85
ndc (package): 62217-316-84
ndc (product): 62217-316
ndc11 (package): 62217031684
ndc11 (package): 62217031685
ndc11 (package): 62217031659
ndc11 (package): 62217031658
spl id: 24c7dec2-2de6-6b27-e063-6394a90a1473
spl set id: 3ec16996-ae86-4f5b-b1fd-c7b509cc5d50

Reported adverse events (FAERS/openFDA)#

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