Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0bc829ff-34a0-03e9-e063-6294a90a10ae
Route
TOPICAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Octocrylene (10 g) Homosalate (2.5 g) Avobenzone
Inactive Ingredients
Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Polymethylsilsesquioxane/trimethylsiloxysilicate Kinetin Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Tocopherol Camellia Oil Apricot Kernel Oil Isododecane Butyloctyl Salicylate Dimethicone Safflower Oil Squalane .alpha.-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-05
Description

Active ingredient, Octocrylene – 10 % Octisalate – 5% Homosalate – 5% Avobenzone – 2.5 %

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses. Helps prevent sunburn.

If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Directions.

Apply generously and evenly 15 minutes before sun exposure.

Reapply: after 40 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours.

Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a broad spectrum SPF value 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 of age: Ask a doctor.

Description

Active ingredient, Octocrylene – 10 % Octisalate – 5% Homosalate – 5% Avobenzone – 2.5 %

Section 50565-1

Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask doctor if skin rash occurs.

Section 50567-7

When using this product keep out of eye.Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive ingredient:

Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active ingredient,

Octocrylene – 10 %

Octisalate – 5%

Homosalate – 5%

Avobenzone – 2.5 %

Section 60561-8

Other information.

Protect this product from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses. Helps prevent sunburn.

If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Directions.

Apply generously and evenly 15 minutes before sun exposure.

Reapply: after 40 minutes of swimming or sweating.

Immediately after towel drying. At least every 2 hours.

Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a broad spectrum SPF value 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 of age: Ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if skin rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eye.Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive ingredient:

Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active ingredient,

Octocrylene – 10 %

Octisalate – 5%

Homosalate – 5%

Avobenzone – 2.5 %

Section 60561-8 (60561-8)

Other information.

Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:26.854714 · Updated: 2026-03-14T23:01:59.101977