FDA.reportPublic FDA data

Fairmont

Manufacturer
Prime Packaging, Inc. | Prime Enterprises
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:48

Label at a glance#

ProductFairmont Broad Spectrum SPF 50
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 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

spray liberally and spread evenly by hand 15 minutes before sun exposure Hold container 4 to 6 inches from the skin to apply Do not spray directly into face. Spray on 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 Sun Protection Measures. Spending time in the sun increase...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.75%

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120F

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Flammable: Do not use near heat, flame or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face. Spray on 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
  • 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 am - 2 pm
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Diethylhexyl 2,6-Napthalate, Mineral Oil (Paraffinum Liquidum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • Avoid spraying on fabrics - could cause discoloration
  • Store at 20 to 25C (68 to 77F)

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-950-2563

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-028713630-0287-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ALCOHOL3K9958V90MIACT
HOMOSALATEV06SV4M95SACTIB
MINERAL OILT5L8T28FGPIACT
OCTISALATE4X49Y0596WACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
COCONUT OILQ9L0O73W7LIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
MONOBUTYL MALEATEF2LD7FVO1LIACT
VINYL ACETATEL9MK238N77IACT
ISOBORNYL ACRYLATEIX0PRH184PIACT

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
1790b341-352d-e370-e063-6394a90a32b81790b341-352c-e370-e063-6394a90a32b82024-05-03WarningsExact identifier
spl id: 1790b341-352d-e370-e063-6394a90a32b8
spl set id: 1790b341-352c-e370-e063-6394a90a32b8

Reported adverse events (FAERS/openFDA)#

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