SPL v1
SPL
SPL Set ID 2aabf782-65f9-e894-e063-6394a90a1ea3
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (4 g) Octinoxate (5 g) Octocrylene (10 g) Titanium Dioxide Octisalate
Inactive Ingredients
Linoleic Acid Water Bisabolol Diethylamino Hydroxybenzoyl Hexyl Benzoate Lecithin, Soybean Phlebodium Aureum Leaf Phenoxyethanol Palmitoyl Pentapeptide-4 Camellia Sinensis Leaf Propanediol Sodium Hyaluronate Carbomer Interpolymer Type A (55000 Cps) Butyrospermum Parkii (shea) Butter Caprylyl Glycol Sodium Ascorbyl Phosphate Calcium Disodium Edta Caprylic/capric Triglyceride Ceteareth-20 Cetearyl Alcohol Hydrogenated Soybean Phosphatidylcholine Polysorbate 20 Xanthan Gum Glyceryl Stearate Se Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01
Description

Octocrylene 10%, sunscreen Octinoxate 5%, sunscreen Octisalate 5%, sunscreen Titanium dioxide 5%, sunscreen Ensulizole 4 %, sunscreen

Purpose

Octocrylene 10%, sunscreen Octinoxate 5%, sunscreen Octisalate 5%, sunscreen Titanium dioxide 5%, sunscreen Ensulizole 4 %, sunscreen

Medication Information

Indications and Usage

.

Purpose

Octocrylene 10%, sunscreen Octinoxate 5%, sunscreen Octisalate 5%, sunscreen Titanium dioxide 5%, sunscreen Ensulizole 4 %, sunscreen

Dosage and Administration

.

Description

Octocrylene 10%, sunscreen Octinoxate 5%, sunscreen Octisalate 5%, sunscreen Titanium dioxide 5%, sunscreen Ensulizole 4 %, sunscreen

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.

Section 50565-1

Keep out of reach of children

Section 51945-4

Warnings

For external use only. Do not swallow.

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

Do not use on damaged or broken skin.

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 .

This product is not formulated for use in children.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

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 value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 AM-2 PM

Wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months of age: ask a doctor.

Inactive Ingredients

BISABOLOL, BUTYROSPERMUM PARKII BUTTER, CALCIUM DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CETEARETH-20, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE S.E., HYDROGENATED PHOSPHATIDYLCHOLINE, LINOLEIC ACID, PALMITOYL PENTAPEPTIDE-4, PHENOXYETHANOL, PHOSPHOLIPIDS, POLYPODIUM LEUCOTOMOS LEAF EXTRACT, POLYSORBATE 20, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, TOCOPHERYL ACETATE, WATER (AQUA), XANTHAN GUM

Active Ingredients , Purpose

Octocrylene 10%, sunscreen

Octinoxate 5%, sunscreen

Octisalate 5%, sunscreen

Titanium dioxide 5%, sunscreen

Ensulizole 4 %, sunscreen

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.

Indications and Usage (34067-9)

.

Dosage and Administration (34068-7)

.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Warnings

For external use only. Do not swallow.

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

Do not use on damaged or broken skin.

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 .

This product is not formulated for use in children.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

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 value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 AM-2 PM

Wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months of age: ask a doctor.

Inactive Ingredients

BISABOLOL, BUTYROSPERMUM PARKII BUTTER, CALCIUM DISODIUM EDTA, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CETEARETH-20, CETEARYL ALCOHOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE S.E., HYDROGENATED PHOSPHATIDYLCHOLINE, LINOLEIC ACID, PALMITOYL PENTAPEPTIDE-4, PHENOXYETHANOL, PHOSPHOLIPIDS, POLYPODIUM LEUCOTOMOS LEAF EXTRACT, POLYSORBATE 20, PROPANEDIOL, SODIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, TOCOPHERYL ACETATE, WATER (AQUA), XANTHAN GUM

Active Ingredients , Purpose (Active ingredients , purpose)

Octocrylene 10%, sunscreen

Octinoxate 5%, sunscreen

Octisalate 5%, sunscreen

Titanium dioxide 5%, sunscreen

Ensulizole 4 %, sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:20.073123 · Updated: 2026-03-14T23:06:57.309434