SPL v1
SPL
SPL Set ID 6d0d1b1f-eaf7-603c-e053-2a91aa0ad307
Route
TOPICAL
Published
Effective Date 2018-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (10 g) Octisalate (5 g) Oxybenzone Octocrylene
Inactive Ingredients
Edetic Acid Water Propylene Glycol Neopentyl Glycol Diheptanoate Tocopherol Trolamine Oleth-3 Alcohol Glycerin Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Polyamide-8 (4500 Mw) Carbomer Interpolymer Type A (55000 Cps) Benzyl Alcohol Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-14
Description

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Use

Helps prevent sunburn.

Label

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. 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 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor.

Active Ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Inactive Ingredients

Water, Propylene Glycol, Neopentyl Glycol Diheptanoate, Polyamide-8, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Oleth-3, Triethanolamine, Fragrance.

Keep Out of Reach of Children.

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

Structured Label Content

Use

Helps prevent sunburn.

Label

Purpose

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. 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 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor.

Active Ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Inactive Ingredients

Water, Propylene Glycol, Neopentyl Glycol Diheptanoate, Polyamide-8, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Oleth-3, Triethanolamine, Fragrance.

Keep Out of Reach of Children.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.785543 · Updated: 2026-03-14T22:55:07.187033