66bb06fb-33d2-4b57-a65f-66bcd187c627

SPL v25
SPL
SPL Set ID 66bb06fb-33d2-4b57-a65f-66bcd187c627
Route
cutaneous
Published
Effective Date 2015-02-05
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
water aloe vera leaf iodopropynyl butylcarbamate stearic acid 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-

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-02-05

Purpose

Sunscreen

Description

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


Medication Information

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.
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.

Purpose

Sunscreen

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

Other Information

•protect this product from excessive heat and direct sun.

Inactive Ingredients

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

Description

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

Section 43683-2

uses 07/2021

directions 07/2021

Section 53413-1

281-835-8051

Bio-Medical & Pharm. Mfg. Corp.

Package Label

pro-tect spf 20 6.4 oz

Active Ingredients

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%


Structured Label Content

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.
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.

Purpose

Sunscreen

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

Other Information

•protect this product from excessive heat and direct sun.

Inactive Ingredients

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

Section 43683-2 (43683-2)

uses 07/2021

directions 07/2021

Section 53413-1 (53413-1)

281-835-8051

Bio-Medical & Pharm. Mfg. Corp.

Package Label (Package label)

pro-tect spf 20 6.4 oz

Active Ingredients (Active ingredients)

Meradimate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%


Advanced Ingredient Data


Raw Label Data

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