FDA.reportPublic FDA data

Florida Suncare

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:12:31

Label at a glance#

ProductFlorida Suncare Broad Spectrum SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, 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

hold container 4 to 6 inches from the skin to apply. spray liberally and spread evenly by hand 15 minutes before sun exposure. do not spray directly into face. Spray on hand then apply to face. do not apply in windy conditions. Use in 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 increa...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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

SPL UNCLASSIFIED SECTION

Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition- No smoking. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • hold container 4 to 6 inches from the skin to apply.
  • spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • do not spray directly into face. Spray on hand then apply to face.
  • do not apply in windy conditions. Use in 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 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats & sunglasses
  • children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cocos Nucifera (coconut) Oil, Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun.
  • avoid spraying on fabrics - could cause discoloration

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 (800) 931-9254

Florida Glow Broad Spectrum SPF 50

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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-023413630-0234-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOBORNYL ACRYLATEIX0PRH184PIACT
ALCOHOL3K9958V90MIACT
VINYL ACETATEL9MK238N77IACT
DIBUTYL MALEATE4X371TMK9KIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
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
0fc6eed5-7a4b-fc92-e063-6394a90a1832b026ec89-ad52-5d44-e053-2995a90aa0152024-01-25WarningsExact identifier
spl id: 0fc6eed5-7a4b-fc92-e063-6394a90a1832
spl set id: b026ec89-ad52-5d44-e053-2995a90aa015

Reported adverse events (FAERS/openFDA)#

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