SPL v5
SPL
SPL Set ID 9604b7d9-d7fc-4cce-ad11-befb7c281fff
Route
CUTANEOUS
Published
Effective Date 2020-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Meradimate (50 mg) Oxybenzone Octisalate
Inactive Ingredients
Water Aloe Vera Leaf Lanolin Iodopropynyl Butylcarbamate Stearic Acid Mineral Oil Talc Trolamine Benzyl Alcohol Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Cetyl Dimethicone 45 Diazolidinyl Urea Diethanolamine Cetyl Phosphate .alpha.-tocopherol Acetate, Dl- Eicosyl Povidone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-08

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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 53413-1

1-800-922-2883

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.

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

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 10

a.m.–2 p.m.

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

sun-glasses

Package Label

NDC# 61619-866-08

Other Information

• Daily usage of Pro-Tect® SPF 30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. • This product provides more than 30 times your natural protection against sunburn. • Very Water Resistant UVA & UVB Broad-Spectrum Protection. • This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

Active Ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.


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 53413-1 (53413-1)

1-800-922-2883

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.

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

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 10

a.m.–2 p.m.

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

sun-glasses

Package Label (Package label)

NDC# 61619-866-08

Other Information

• Daily usage of Pro-Tect® SPF 30+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. • This product provides more than 30 times your natural protection against sunburn. • Very Water Resistant UVA & UVB Broad-Spectrum Protection. • This product may stain light colored fabrics if washed with bleach. Wash clothing without bleach to remove safely.

Active Ingredients (Active ingredients)

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 5.0%

Inactive Ingredients

Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water.


Advanced Ingredient Data


Raw Label Data

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