2a845e4c-86e7-1799-e063-6294a90a9b2b

SPL v1
SPL
SPL Set ID 2a845e4c-86e7-1799-e063-6294a90a9b2b
Route
topical
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (5 g) octocrylene (10 g) octisalate (4 g) ensulizole octinoxate
Inactive Ingredients
glyceryl stearate se lecithin, soybean ceteareth-20 palmitoyl pentapeptide-4 phlebodium aureum leaf calcium disodium edta butyrospermum parkii (shea) butter hydrogenated soybean phosphatidylcholine xanthan gum alpha-tocopherol acetate bisabolol ci 77491 ci 77492 ci 77499 polysorbate 20 water sodium hyaluronate caprylic/capric triglyceride linoleic acid caprylyl glycol camellia sinensis leaf diethylamino hydroxybenzoyl hexyl benzoate carbomer interpolymer type a (55000 cps) cetearyl alcohol sodium ascorbyl phosphate phenoxyethanol propanediol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-01
Purpose

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

Description

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

Medication Information

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.

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

.

Purpose

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

Dosage and Administration

.

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, 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.

Description

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

Section 50565-1

Keep out of reach of children

Active Ingredients , Purpose

Octocrylene 10%, sunscreen

Octinoxate 5%, sunscreen

Octisalate 5%, sunscreen

Titanium dioxide 5%, sunscreen

Ensulizole 4 %, sunscreen

Exel Clarifying Line Daily Fluid Sun Shield Walnut Brown Color Broad Spectrum Spf 60+

Structured Label Content

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.

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)

.

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 (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, 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 50565-1 (50565-1)

Keep out of reach of children

Active Ingredients , Purpose (Active ingredients , purpose)

Octocrylene 10%, sunscreen

Octinoxate 5%, sunscreen

Octisalate 5%, sunscreen

Titanium dioxide 5%, sunscreen

Ensulizole 4 %, sunscreen

Exel Clarifying Line Daily Fluid Sun Shield Walnut Brown Color Broad Spectrum Spf 60+ (EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60+)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.355841 · Updated: 2026-03-14T23:06:57.309434