DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (75 mg) Meradimate (50 mg) Oxybenzone (30 mg) Octisalate

Inactive Ingredients

Aloe Vera Leaf Benzyl Alcohol Diazolidinyl Urea Cetyl Alcohol Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetyl Dimethicone 45 Diethanolamine Cetyl Phosphate .alpha.-tocopherol Acetate, Dl- Iodopropynyl Butylcarbamate Stearic Acid Talc Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-05-01

Medication Information

Purpose

Sunscreen

Description

Meradimate 5.0% Octinoxate 7.5% Octisalate 5.0% Oxybenzone 3.0%

Uses

•helps prevent sunburn.

•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.

Section 43683-2

Uses 12/2020

Directions 12/2020

Section 50565-1

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes.

Rinse with water to remove.

Directions

•apply liberally 15 minutes before sun exposure

•reapply:

•after 80 minutes of swimming or sweating

•immediately after towel drying

•at least every 2 hours

•children under 6 months: Ask a doctor

• 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 value of 15 or higher and other

sun protection measures including:

•limit time in the sun, especially from 10a.m.–2 p.m.

•wear long-sleeved shirts, pants, hats, and sun-glasses

Package Label

A-CUTE DERM ®

medical skincare

PRO-TECT

SPF 20

SUNSCREEN

8.0 FL OZ (236.6 ml)

Other Information

•protect this product from excessive heat and direct sun.

Active Ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Questions Or Comments

Dist. by ABBE Laboratories, Inc. • 1095 Route 110

Farmingdale, NY 11735 • 1-800-457-0990

Structured Label Content

Uses

•helps prevent sunburn.

•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.

Section 43683-2 (43683-2)

Uses 12/2020

Directions 12/2020

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Purpose

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes.

Rinse with water to remove.

Directions

•apply liberally 15 minutes before sun exposure

•reapply:

•after 80 minutes of swimming or sweating

•immediately after towel drying

•at least every 2 hours

•children under 6 months: Ask a doctor

• 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 value of 15 or higher and other

sun protection measures including:

•limit time in the sun, especially from 10a.m.–2 p.m.

•wear long-sleeved shirts, pants, hats, and sun-glasses

Package Label

A-CUTE DERM ®

medical skincare

PRO-TECT

SPF 20

SUNSCREEN

8.0 FL OZ (236.6 ml)

Other Information

•protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.

Questions Or Comments (Questions or Comments)

Dist. by ABBE Laboratories, Inc. • 1095 Route 110

Farmingdale, NY 11735 • 1-800-457-0990

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "•helps prevent sunburn. •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.", "43683-2": "Uses 12/2020 Directions 12/2020", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Sunscreen", "Warnings": "For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.", "Directions": "•apply liberally 15 minutes before sun exposure •reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •children under 6 months: Ask a doctor • 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 value of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10a.m.–2 p.m. •wear long-sleeved shirts, pants, hats, and sun-glasses", "Package Label": "A-CUTE DERM ® medical skincare PRO-TECT SPF 20 SUNSCREEN 8.0 FL OZ (236.6 ml)", "Other Information": "•protect this product from excessive heat and direct sun.", "Active ingredients": "Meradimate 5.0% Octinoxate 7.5% Octisalate 5.0% Oxybenzone 3.0%", "Inactive Ingredients": "Aloe Vera Leaf, Benzyl Alcohol, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phospate, dl-Alpha Tocopheryl Acetate, Iodopropynyl Butylcarbamate, Stearic Acid, Talc, Trolamine, Water.", "Questions or Comments": "Dist. by ABBE Laboratories, Inc. • 1095 Route 110 Farmingdale, NY 11735 • 1-800-457-0990"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information