SPL v4
SPL
SPL Set ID 14e3df1d-48f5-1e28-e054-00144ff8d46c
Route
CUTANEOUS
Published
Effective Date 2015-05-05
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 2015-05-15

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

• Pro-Tect® SPF 30+ Broad-Spectrum UVA & UVB protection. • Helps prevent sunburn. • Retains a SPF of 30+ after 80 minutes of activity in water or perspiring. • Provides high protection against sunburn and tanning. • For skin highly sensitive to sunburn.

Section 53413-1

Bio-Medical & Pharm. Mfg. Corp., 4311 South Dr.,Houston, TX 77053-4820, 281-835-8051, M-F 8AM-5PM, www.protectsunscreen.com

Warnings

• External use only. • 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. • Do not use if sensitive to any of the ingredients or their related compounds.

Directions

•Apply this product topically to affected areas and allow to dry without rubbing. •Use up to 3 times daily. •Use only as directed.

Package Label

SUNSCREEN FOR PROFESSIONALS

PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN

PRO-TECT

Water-Resistant

Fragrance-Free

Aloe & vitamin E

SPF 30+

18.8 kg /5 gal.

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.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN


Structured Label Content

Uses

• Pro-Tect® SPF 30+ Broad-Spectrum UVA & UVB protection. • Helps prevent sunburn. • Retains a SPF of 30+ after 80 minutes of activity in water or perspiring. • Provides high protection against sunburn and tanning. • For skin highly sensitive to sunburn.

Section 53413-1 (53413-1)

Bio-Medical & Pharm. Mfg. Corp., 4311 South Dr.,Houston, TX 77053-4820, 281-835-8051, M-F 8AM-5PM, www.protectsunscreen.com

Purpose

Sunscreen

Warnings

• External use only. • 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. • Do not use if sensitive to any of the ingredients or their related compounds.

Directions

•Apply this product topically to affected areas and allow to dry without rubbing. •Use up to 3 times daily. •Use only as directed.

Package Label (Package label)

SUNSCREEN FOR PROFESSIONALS

PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN

PRO-TECT

Water-Resistant

Fragrance-Free

Aloe & vitamin E

SPF 30+

18.8 kg /5 gal.

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.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)