FDA.reportPublic FDA data

HIGHHEAT Sunscreen SPF 50 Performance For Athletes

Manufacturer
DUGOUT ESSENTIALS LLC | Pure Source, LLC
Effective date
2025-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:29

Label at a glance#

ProductHIGHHEAT Sunscreen SPF 50 Performance For Athletes
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 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

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. do not spray directly on face. Spray into hands and apply to face. Use in well-ventilated areas. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

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.
  • Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • do not spray directly on face. Spray into hands and apply to face.
  • Use in well-ventilated areas.
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, Alcohol, Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Butyloctyl Salicylate, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Fragrance (Parfum), Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate

Questions?

OTC - QUESTIONS SECTION

319-298-2923

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85840-622-00HIGHHEAT Sunscreen SPF 50 Performance For Athletes177 mL in 1 CANLIQUID1771

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85840-62285840-622-00

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
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
SUNFLOWER OIL3W1JG795YIIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
HIGHHEAT Sunscreen SPF 50 Performance For AthletesAVOBENZONE, OCTISALATE, OCTOCRYLENEDUGOUT ESSENTIALS LLC3b7cddb5-00d2-4998-8eec-5e5a7c5a60972025-07-03WarningsExact identifier
ndc (package): 85840-622-00
ndc (product): 85840-622
ndc11 (package): 85840062200
spl id: 38c66a1a-7ff0-4757-e063-6394a90a2168
spl set id: 3b7cddb5-00d2-4998-8eec-5e5a7c5a6097

Reported adverse events (FAERS/openFDA)#

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