FDA.reportPublic FDA data

Fruit of the Earth Sun Town City SPF 50 Sunscreen

Manufacturer
Fruit of the Earth, Inc.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:14

Label at a glance#

ProductFruit of the Earth Sun Town City SPF 50 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure12 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 caused 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 and other ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%

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 caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

• rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

  • 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

ozokerite, C12-15 alkyl benzoate, paraffin, adipic acid/diglycol crosspolymer, beeswax, octyldodecyl neopentanoate, dimethicone, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, caprylyl glycol, tocopherol, fragrance.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83669E83669E

83669K83669K

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-076-84Fruit of the Earth Sun Town City SPF 50 Sunscreen17 g in 1 CONTAINERSTICK172
62217-076-85Fruit of the Earth Sun Town City SPF 50 Sunscreen1 in 1 BLISTER PACKSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-076FRUIT OF THE EARTH SUN TOWN CITY SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [FRUIT OF THE EARTH, INC.]2Current NDC, Legacy NDC, 2 package rows20241019_c7bbad46-5c52-9f1d-e053-2995a90ae139.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-07662217-076-84, 62217-076-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
WHITE WAX7G1J5DA97FIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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 City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bbad46-5c52-9f1d-e053-2995a90ae1392024-10-17WarningsExact identifier
ndc (package): 62217-076-84
ndc (package): 62217-076-85
ndc (product): 62217-076
ndc11 (package): 62217007685
ndc11 (package): 62217007684
spl id: 24b3ddfe-5a3e-0b8e-e063-6394a90a61cf
spl set id: c7bbad46-5c52-9f1d-e053-2995a90ae139

Reported adverse events (FAERS/openFDA)#

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