SPL v6
SPL
SPL Set ID 16994959-cade-06de-e054-00144ff88e88
Route
CUTANEOUS
Published
Effective Date 2015-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2015-05-27

Description

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

Purpose

Sunscreen


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 07/2021

Directions 07/2021

Section 53413-1

281-835-8051

Bio-Med & Pharm. Mfg. Corp.

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

pro-tect spf 20

3.4 oz

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.


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 07/2021

Directions 07/2021

Section 53413-1 (53413-1)

281-835-8051

Bio-Med & Pharm. Mfg. Corp.

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)

pro-tect spf 20

3.4 oz

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.


Advanced Ingredient Data


Raw Label Data

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