Summer Face Sunscreen Spf 50

Summer Face Sunscreen Spf 50
SPL v1
SPL
SPL Set ID fe256ff4-cb92-4262-8ab9-7cc912e0af22
Route
TOPICAL
Published
Effective Date 2025-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Ethylhexyl Salicylate (50 mg) Octocrylene (75 mg)
Inactive Ingredients
1,2-hexanediol Aminomethylpropanol Butylene Glycol Caprylyl Trisiloxane Cetearyl Olivate Decyl Glucoside Dodecane Ethylhexylglycerin Glycerin Ferric Oxide Red Ferric Oxide Yellow Rice Bran Phenoxyethanol Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Polysorbate 20 Potassium Cetyl Phosphate Propanediol Rosemary Sodium Stearoyl Glutamate Sorbitan Olivate Sorbitan Stearate Tetrasodium Edta Tocopherol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-04
Description

Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 7.5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 7.5%

Uses:

• Helps prevent sunburn. • Higher SPF gives moresunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do Not Use

on damaged or broken skin.

Drug Facts

Directions:

Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • Reapply: after 80 minutes of swimming or sweating. • Immediately after towel drying. • 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 the 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 10am-2pm. • Wear long-sleeved shirts, pants, hats, & sunglasses.

Package Labeling:

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 7.5%

Other Information:

Protect the product in this container from excessive heatand direct sun.

Inactive Ingredients:

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Brassica Napus (Rapeseeds) Glycerides, Butylene Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Methicone, Cetearyl Olivate, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Stearate, Tetrasodium EDTA, Tocopherol, Water (Aqua)

When Using This product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor
  • if rash or irritation develops and lasts.
If Pregnant Or Breast Feeding,

ask a health professional before use.

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. • Higher SPF gives moresunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Warnings:

For external use only.

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Directions:

Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • Reapply: after 80 minutes of swimming or sweating. • Immediately after towel drying. • 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 the 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 10am-2pm. • Wear long-sleeved shirts, pants, hats, & sunglasses.

Package Labeling:

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 7.5%

Other Information:

Protect the product in this container from excessive heatand direct sun.

Inactive Ingredients:

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Brassica Napus (Rapeseeds) Glycerides, Butylene Glycol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Methicone, Cetearyl Olivate, Decyl Glucoside, Dodecane, Ethylhexylglycerin, Glycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 20, Potassium Cetyl Phosphate, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Stearate, Tetrasodium EDTA, Tocopherol, Water (Aqua)

When Using This product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if rash or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:37.676562 · Updated: 2026-03-14T23:12:56.390264