2caaedee-7aea-df02-e063-6394a90ab1db

SPL v1
SPL
SPL Set ID 2caaedee-7aea-df02-e063-6394a90ab1db
Route
topical
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (9 mg) homosalate (16.2 mg) avobenzone (5.4 mg) octisalate (7.2 mg)
Inactive Ingredients
silica steareth-21 sorbitan isostearate butylene glycol aloe barbadensis leaf water c14-22 alcohols water butyloctyl salicylate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) polysorbate 60 dimethicone/vinyl dimethicone crosspolymer (soft particle) phenoxyethanol chlorphenesin edetate disodium panthenol trehalose c12-20 alkyl glucoside

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-27

Purpose

Sunscreen

Description

OCTOCRYLENE OCTISALATE AVOBENZONE HOMOSALATE


Medication Information

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 .

Uses

Uses: Helps prevent sunburn.

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

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.

Inactive Ingredients

BUTYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYSORBATE 60

SORBITAN ISOSTEARATE

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

PANTHENOL

ALOE BARBADENSIS LEAF WATER

Description

OCTOCRYLENE OCTISALATE AVOBENZONE HOMOSALATE

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 .

Do Not Use

Do not use on broken or damaged skin .

Stop use and ask a doctor if rash occurs

Package Label

Active Ingredients

OCTOCRYLENE

OCTISALATE

AVOBENZONE

HOMOSALATE

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

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 .

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

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.

Inactive Ingredients

BUTYLENE GLYCOL

WATER

C14-22 ALCOHOLS

C12-20 ALKYL GLUCOSIDE

BUTYLOCTYL SALICYLATE

STEARETH-21

HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER

POLYSORBATE 60

SORBITAN ISOSTEARATE

TREHALOSE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

SILICA

PHENOXYETHANOL

CHLORPHENESIN

FRAGRANCE

DISODIUM EDTA

PANTHENOL

ALOE BARBADENSIS LEAF WATER

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 .

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

OCTOCRYLENE

OCTISALATE

AVOBENZONE

HOMOSALATE

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

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