FDA.reportPublic FDA data

HOMOSALATE, OCTISALATE

Manufacturer
FRUIT OF THE EARTH, INC.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:52:01

Label at a glance#

ProductFOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN
Active ingredientHOMOSALATE, OCTISALATE
Label structure13 sections

Indications and uses

helps prevent sunburn

Dosage and administration

Spray liberally and spread evenly by hand 15 minutes before sun exposure Hold can 4-6 inches away from the skin to apply Do not spray directly into face. Spray into hands then apply to face Do not apply in windy conditions Use in a well-ventilated area. 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

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

Homosalate 7.0%, Octisalate 5.0%

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.

FLAMMABLE:

WARNINGS AND PRECAUTIONS SECTION

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

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 • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area.
  • 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

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

alcohol denat., mineral oil, tridecyl salicylate, fragrance, acrylates/octylacrylamide copolymer, tocopheryl acetate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83241D183241D1

83281D183281D1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62217-04262217-042-37, 62217-042-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
MINERAL OILT5L8T28FGPIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)JU3XHR8VWKIACT
HONEYY9H1V576FHIACT
BRAZIL NUT OIL0G89T29HO6IACT
CRANBERRY SEED OIL73KDS3BW5EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
24b35fac-b6c9-2398-e063-6394a90af56cb6b9c6ff-3d7e-45e8-b764-62667e7339052024-10-17WarningsExact identifier
spl id: 24b35fac-b6c9-2398-e063-6394a90af56c
spl set id: b6b9c6ff-3d7e-45e8-b764-62667e733905

Reported adverse events (FAERS/openFDA)#

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