Soleil Superieur Broad Spectrum Spf 50 Sunscreen Us

Soleil Superieur Broad Spectrum Spf 50 Sunscreen Us
SPL v3
SPL
SPL Set ID cf0000e8-98f8-4e36-bbdd-8c301b73b3e1
Route
TOPICAL
Published
Effective Date 2022-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (26 mg)
Inactive Ingredients
Water Dipropylene Glycol Caprylyl Trisiloxane Dicaprylyl Carbonate Peg/ppg-17/6 Copolymer Potassium Cetyl Phosphate Thermus Thermophilus Lysate Peg-100 Stearate Glyceryl Monostearate Methyl Glucose Sesquistearate Alcohol .alpha.-tocopherol Acetate Carnosine Adenosine Polygonum Aviculare Top Glycerin Panthenol Tocopherol Sodium Oleate Soybean Oil Hydrogenated Palm Glycerides Cetyl Alcohol Caprylyl Glycol Isohexadecane Silibinin Potassium Sorbate Potassium Hydroxide Hexylene Glycol Sorbitan Monooleate Glycyrrhizinate Dipotassium Sodium Benzoate Phenoxyethanol Polysorbate 80 Edetate Disodium Anhydrous Disodium Lauryl Sulfosuccinate Sodium Laureth-12 Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.6%

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

For external use only.

Directions

• For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • 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 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor













Sun Protection Measures.

Do Not Use

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

Inactive Ingredients:

Aqua (Water, Eau), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Carnosine, Adenosine, Polygonum Aviculare Extract, Glycerin, Panthenol, Tocopherol, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydrogenated Palm Glycerides, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Caprylyl Glycol, Isohexadecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lecithin, Silybin, Potassium Sorbate, Potassium Hydroxide, Hexylene Glycol, Sorbitan Oleate, Parfum (Fragrance), Dipotassium Glycyrrhizate, C11-15 Alketh-7, C11-15 Alketh-40, Sodium Benzoate, Phenoxyethanol, Polyacrylate-15, Polyacrylate-17, Polysorbate 80, Disodium EDTA, PEG-10 Dimethicone, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate.

Questions Or Comments?

Call , M – F 8am – 5pm CST. 1-866-986-7083

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.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• helps prevent sunburn

• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Purpose

Sunscreen

Warnings

For external use only.

Directions

• For sunscreen use: • apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • 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 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor













Sun Protection Measures.

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.6%

Inactive Ingredients: (Inactive ingredients:)

Aqua (Water, Eau), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Thermus Thermophillus Ferment, PEG-100 Stearate, Glyceryl Stearate, Methyl Glucose Sesquistearate, Alcohol Denat., Oligopeptide-24, Tocopheryl Acetate, Carnosine, Adenosine, Polygonum Aviculare Extract, Glycerin, Panthenol, Tocopherol, Sodium Oleate, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydrogenated Palm Glycerides, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Alcohol, Caprylyl Glycol, Isohexadecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Lecithin, Silybin, Potassium Sorbate, Potassium Hydroxide, Hexylene Glycol, Sorbitan Oleate, Parfum (Fragrance), Dipotassium Glycyrrhizate, C11-15 Alketh-7, C11-15 Alketh-40, Sodium Benzoate, Phenoxyethanol, Polyacrylate-15, Polyacrylate-17, Polysorbate 80, Disodium EDTA, PEG-10 Dimethicone, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate.

Questions Or Comments? (Questions or comments?)

Call , M – F 8am – 5pm CST. 1-866-986-7083

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)