SPL v1
SPL
SPL Set ID 2caa603b-dda0-1d9c-e063-6294a90a01d0
Route
TOPICAL
Published
Effective Date 2025-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5.4 mg) Octisalate (9 mg) Titanium Dioxide
Inactive Ingredients
Cyclohexasiloxane Water Glycerin Aluminum Hydroxide Behenyl Alcohol Arachidyl Glucoside Phenoxyethanol Polysorbate 60 Cyclopentasiloxane Edetate Disodium Propylene Glycol Xanthan Gum Dipropylene Glycol C12-15 Alkyl Benzoate Arachidyl Alcohol Allantoin 1,2-hexanediol Alcohol Stearic Acid Chlorphenesin Triethanolamine Cetyl Ethylhexanoate Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-27

Description

OCTISALATE TITANIUM DIOXIDE OCTOCRYLENE

Purpose

Sunscreen


Medication Information

Indications and Usage

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Purpose

Sunscreen

Description

OCTISALATE TITANIUM DIOXIDE OCTOCRYLENE

Uses

Uses: Helps prevent sunburn.

Stop Use

Stop use and ask a doctor if rash occurs

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

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

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away

Warnings

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away .

Directions

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Do Not Use

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

Package Label

Active Ingredients

OCTISALATE

TITANIUM DIOXIDE

OCTOCRYLENE

Inactive Ingredients

CYCLOHEXASILOXANE

WATER

CYCLOPENTASILOXANE

GLYCERIN

PROPYLENE GLYCOL

ALCOHOL

CETYL ETHYLHEXANOATE

ALUMINUM HYDROXIDE

STEARIC ACID

DIPROPYLENE GLYCOL

C12-15 ALKYL BENZOATE

ARACHIDYL ALCOHOL

BEHENYL ALCOHOL

ARACHIDYL GLUCOSIDE

PHENOXYETHANOL

1,2-HEXANEDIOL

CHLORPHENESIN

POLYSORBATE 60

ALLANTOIN

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

XANTHAN GUM

DISODIUM EDTA

Keep Out of Reach of Children

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away


Structured Label Content

Uses

Uses: Helps prevent sunburn.

Indications and Usage (34067-9)

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs

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

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

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away

Warnings

For external use only .

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away .

Directions

Directions : Apply liberally 15 minutes before sun or water exposure. Works best on

moisturized skin.

Reapply:

After 80 minutes of swimming or sweating.

Immediately after towel drying.

At least every 2 hours.

Children under 6 months: Ask a doctor.

Do Not Use (Do not use)

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

Package Label

Active Ingredients

OCTISALATE

TITANIUM DIOXIDE

OCTOCRYLENE

Inactive Ingredients

CYCLOHEXASILOXANE

WATER

CYCLOPENTASILOXANE

GLYCERIN

PROPYLENE GLYCOL

ALCOHOL

CETYL ETHYLHEXANOATE

ALUMINUM HYDROXIDE

STEARIC ACID

DIPROPYLENE GLYCOL

C12-15 ALKYL BENZOATE

ARACHIDYL ALCOHOL

BEHENYL ALCOHOL

ARACHIDYL GLUCOSIDE

PHENOXYETHANOL

1,2-HEXANEDIOL

CHLORPHENESIN

POLYSORBATE 60

ALLANTOIN

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

TRIETHANOLAMINE

XANTHAN GUM

DISODIUM EDTA

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children . If product is swallowed , get medical help or contact a

Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)