Chemical Sunscreen Spf50 With Antipollution

Chemical Sunscreen Spf50 With Antipollution
SPL v1
SPL
SPL Set ID 59efb7dd-83f9-4222-9b7e-ea17ac4ece00
Route
TOPICAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (150 g) Octocrylene (100 g) Avobenzone (30 g) Octisalate (50 g)
Inactive Ingredients
Water C15-19 Alkane Triheptanoin Dicaprylyl Carbonate Butyloctyl Salicylate Glycerin Coco-glucoside Argania Spinosa Seed Phenoxyethanol Ethylhexylglycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Polysorbate 60 Sorbitan Isostearate Triacontanyl Pvp (wp-660) Biosaccharide Gum-4 1,2-hexanediol C13-16 Isoparaffin Ethylhexyl Methoxycrylene Cetostearyl Alcohol Anhydrous Dextrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-18

Description

For external use only. 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

For external use only. 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Labeling

Warnings

For external use only. 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Questions

Call toll free 1-866-416-2366

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Active Ingredients

Homosalate 15.0% Sunscreen

Octocrylene 10.0% Sunscreen

Avobenzone 3.0% Sunscreen

Octisalate 5.0% Sunscreen

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, C15-19 Alkane, Triheptanoin C13-16 Isoalkane, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Cetearyl alcohol, Coco-Glucoside, Glucose, Argania Spinosa Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Triacontanyl PVP, Biosaccharide Gum-4, 1,2-Hexanediol

Indications and Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Purpose

Sunscreen

Labeling

Warnings

For external use only. 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Questions

Call toll free 1-866-416-2366

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Active Ingredients

Homosalate 15.0% Sunscreen

Octocrylene 10.0% Sunscreen

Avobenzone 3.0% Sunscreen

Octisalate 5.0% Sunscreen

Other Information: (Other information:)

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, C15-19 Alkane, Triheptanoin C13-16 Isoalkane, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Cetearyl alcohol, Coco-Glucoside, Glucose, Argania Spinosa Kernel Oil, Phenoxyethanol, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Triacontanyl PVP, Biosaccharide Gum-4, 1,2-Hexanediol

Indications and Uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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