chemical sunscreen spf50

chemical sunscreen spf50
SPL v2
SPL
SPL Set ID 50f47495-93aa-4e11-a153-d4c847a36c99
Route
topical
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (50 g) avobenzone (30 g) homosalate (150 g) octocrylene (100 g)
Inactive Ingredients
water glycerin phenoxyethanol ethylhexylglycerin argan oil triheptanoin coco-glucoside dextrose cetostearyl alcohol butyloctyl salicylate triacontanyl pvp (wp-660) dicaprylyl carbonate ethylhexyl methoxycrylene hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) isohexadecane polysorbate 60

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-29

Purpose

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.

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.


Medication Information

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.

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.

Purpose

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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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.

Inactive Ingredients

Water, Dicaprylyl Carbhonate, Triheptanoin C13-16 Isoalkane, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Triacontanyl PVP, Phenoxyethanol, Ethylhexylglycerin, Ceterayl Alcohol, Coco-

Glucoside, Glucose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexane, Polysorbate 60, Sorbitan Isostearate.

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

Questions

Call toll free 1-866-416-2366

Active Ingredients

Avobenzone 3.0% Sunscreen

Octisalate 5.0% Sunscreen

Octocrylene 10.0% Sunscreen

Homosalate 15.0% Sunscreen

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN 


Structured Label Content

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.

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.

Purpose

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.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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.

Inactive Ingredients

Water, Dicaprylyl Carbhonate, Triheptanoin C13-16 Isoalkane, Butyloctyl Salicylate, Glycerin, Ethylhexyl Methoxycrylene, Triacontanyl PVP, Phenoxyethanol, Ethylhexylglycerin, Ceterayl Alcohol, Coco-

Glucoside, Glucose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexane, Polysorbate 60, Sorbitan Isostearate.

Labeling

Questions

Call toll free 1-866-416-2366

Active Ingredients

Avobenzone 3.0% Sunscreen

Octisalate 5.0% Sunscreen

Octocrylene 10.0% Sunscreen

Homosalate 15.0% Sunscreen

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)