Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 50a73743-ca4b-471a-b337-ebf73a4b4ba4
Route
TOPICAL
Published
Effective Date 2013-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene
Inactive Ingredients
Water Ethylhexyl Palmitate Sorbitol Benzyl Alcohol Dimethicone Glyceryl Monostearate Peg-100 Stearate Trolamine Edetate Disodium Tocopherol Aloe Vera Leaf Chlorphenesin Oleth-3 Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-06
Description

Avobenzone   3.0% Homosalate   10.0% Octisalate       5.0% Octocrylene    10.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone   3.0% Homosalate   10.0% Octisalate       5.0% Octocrylene    10.0%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
Warnings

For external use only. Do not use on damaged or broken skin.

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-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Other Information
  •  protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone   3.0%

Homosalate   10.0%

Octisalate       5.0%

Octocrylene    10.0%

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Questions Or Comments?

Call 1-386-673-2024



Principal Display Panel

exchange select

X

SUNSCREEN

lotion

30

BROAD SPECTRUM

SPF 30

UVA/UVB Protection

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)







When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin.

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-sleeve shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Other Information
  •  protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone   3.0%

Homosalate   10.0%

Octisalate       5.0%

Octocrylene    10.0%

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Questions Or Comments? (Questions or comments?)

Call 1-386-673-2024



Principal Display Panel

exchange select

X

SUNSCREEN

lotion

30

BROAD SPECTRUM

SPF 30

UVA/UVB Protection

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)







When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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. May stain some fabrics.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.959123 · Updated: 2026-03-14T22:53:34.467425