Highheat Sunscreen Spf 50 Performance For Athletes

Highheat Sunscreen Spf 50 Performance For Athletes
SPL v1
SPL
SPL Set ID 3b7cddb5-00d2-4998-8eec-5e5a7c5a6097
Route
TOPICAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Ethylhexyl Salicylate (50 mg) Octocrylene
Inactive Ingredients
Alcohol Aloe Vera Leaf Ascorbyl Palmitate Butyloctyl Salicylate Chamomile Cucumber Sunflower Oil .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-18

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%

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.
Warnings

For external use only

Directions
  • 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.
Questions?

319-298-2923

Do Not Use 
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Inactive Ingredients

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

When Using This Product
  • 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 
  • rash or irritation develops and lasts.

Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only

Directions
  • 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.
Questions?

319-298-2923

Do Not Use  (Do not use )
  • on damaged or broken skin.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Inactive Ingredients

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

When Using This Product (When using this product)
  • 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • rash or irritation develops and lasts.

Advanced Ingredient Data


Raw Label Data

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