FDA.reportPublic FDA data

Fruit of the Earth Sun Town City Dark Tanning SPF 8 Lotion 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 Dark Tanning SPF 8 Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure12 sections

Indications and uses

• helps prevent sunburn

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 1.5%, Octisalate 5.0%, Octocrylene 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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

water, octyldodecyl neopentanoate, glycerin, butyloctyl salicylate, cetearyl alcohol, polysorbate 60, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, triethanolamine, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83650EF83650EF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-072-11Fruit of the Earth Sun Town City Dark Tanning SPF 8 Sunscreen237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-072FRUIT OF THE EARTH SUN TOWN CITY DARK TANNING SPF 8 SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [FRUIT OF THE EARTH, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_c7aa1e58-f7b3-6b7f-e053-2995a90a957c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-07262217-072-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TROLAMINE9O3K93S3TKIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
DIPROPYLENE GLYCOLE107L85C40IACT
2,6-DIMETHYL-5-HEPTENALZ331YX9EL9IACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEG-100 STEARATEYD01N1999RIACT
EDETATE DISODIUM7FLD91C86KIACT
AVOBENZONEG63QQF2NOXACTIB
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 Dark Tanning SPF 8 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aa1e58-f7b3-6b7f-e053-2995a90a957c2024-10-17WarningsExact identifier
ndc (package): 62217-072-11
ndc (product): 62217-072
ndc11 (package): 62217007211
spl id: 24b3ce78-5fdc-eda3-e063-6394a90a54b7
spl set id: c7aa1e58-f7b3-6b7f-e053-2995a90a957c

Reported adverse events (FAERS/openFDA)#

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