SPL v3
SPL
SPL Set ID a22c6359-435d-626b-e053-2a95a90ae0c6
Route
TOPICAL
Published
Effective Date 2020-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Homosalate (15 g) Octocrylene (8 g)
Inactive Ingredients
Alcohol Glycerin Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Caprylyl Trisiloxane Medium-chain Triglycerides Diethylhexyl Syringylidenemalonate Stearoxytrimethylsilane Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-31

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Uses
  • Helps prevent sunburn
Label

Warnings

For external use only. Flammable: do not use while smoking or near heat or flame.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

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 no apply in windy conditions. Use in a well-ventilated area.

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethysilane, Tocopherol.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Helps prevent sunburn
Label

Purpose

Sunscreen

Warnings

For external use only. Flammable: do not use while smoking or near heat or flame.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

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 no apply in windy conditions. Use in a well-ventilated area.

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethysilane, Tocopherol.

Keep Out of Reach of Children.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)