SPL v1
SPL
SPL Set ID 2aad5b97-e64b-c678-e063-6294a90aa8c6
Route
TOPICAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Octisalate (5 g) Octinoxate (4 g) Titanium Dioxide Ensulizole
Inactive Ingredients
Hydrogenated Soybean Phosphatidylcholine Caprylic/capric Triglyceride Linoleic Acid Glyceryl Stearate Se Palmitoyl Pentapeptide-4 Calcium Disodium Edta Xanthan Gum Phenoxyethanol Ceteareth-20 Carbomer Interpolymer Type A (55000 Cps) Bisabolol Ci 77491 Ci 77492 Polysorbate 20 Caprylyl Glycol Diethylamino Hydroxybenzoyl Hexyl Benzoate Propanediol Alpha-tocopherol Acetate Lecithin, Soybean Phlebodium Aureum Leaf Butyrospermum Parkii (shea) Butter Ci 77499 Water Camellia Sinensis Leaf Sodium Hyaluronate Cetearyl Alcohol Sodium Ascorbyl Phosphate

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 51727-6

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, IRON OXIDE BLACK (CI 77499), IRON OXIDE RED (CI 77491), IRON OXIDE YELLOW (CI 77492), 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.

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.

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 51727-6 (51727-6)

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, IRON OXIDE BLACK (CI 77499), IRON OXIDE RED (CI 77491), IRON OXIDE YELLOW (CI 77492), 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.

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.

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:20.076814 · Updated: 2026-03-14T23:06:57.309434