FDA.reportPublic FDA data

SPA COLOGY SPORT SUNSCREEN LOTION SPF 50

Manufacturer
FRUIT OF THE EARTH, INC.
Effective date
2021-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:02

Label at a glance#

ProductFOTE SPORT SUNSCREEN SPF 50
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 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 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 10.0%, Octisalate 4.5%, Octocrylene 8.0%

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

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, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPA COLOGY SPORT SUNSCREEN LOTION SPF 50

8.0 FL OZ (237mL)

NDC 62217-052-11

SP29033EFSP29033EF

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-05262217-052-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISODODECANEA8289P68Y2IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
WHITE WAX7G1J5DA97FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
DOCOSANOL9G1OE216XYIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT

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
24b39196-e2d3-7a44-e063-6394a90a38d2c55ff3be-b58e-e87b-e053-2a95a90af4dd2024-10-17WarningsExact identifier
spl set id: c55ff3be-b58e-e87b-e053-2a95a90af4dd

Reported adverse events (FAERS/openFDA)#

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