SPL v1
SPL
SPL Set ID db6085a7-8416-a4bb-e053-2995a90a35dc
Route
TOPICAL
Published
Effective Date 2022-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-31

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
  • 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.
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, 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
  • 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.
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, 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

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