NDC 37945-862 Pro-tect Sports Sunscreen

Meradimate, Octinoxate, Octisalate, Oxybenzone

NDC Product Code 37945-862

NDC CODE: 37945-862

Proprietary Name: Pro-tect Sports Sunscreen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Meradimate, Octinoxate, Octisalate, Oxybenzone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 37945 - Bio-medical & Pharmaceutical Manufacturing Corporation

NDC 37945-862-64

Package Description: 100 g in 1 BOTTLE

NDC 37945-862-65

Package Description: 190 g in 1 CONTAINER

NDC Product Information

Pro-tect Sports Sunscreen with NDC 37945-862 is a a human over the counter drug product labeled by Bio-medical & Pharmaceutical Manufacturing Corporation. The generic name of Pro-tect Sports Sunscreen is meradimate, octinoxate, octisalate, oxybenzone. The product's dosage form is lotion and is administered via cutaneous form.

Labeler Name: Bio-medical & Pharmaceutical Manufacturing Corporation

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pro-tect Sports Sunscreen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTISALATE 50 mg/g
  • OCTINOXATE 75 mg/g
  • MERADIMATE 50 mg/g
  • OXYBENZONE 30 mg/g
  • OCTINOXATE 75 mg/g
  • MERADIMATE 50 mg/g
  • OXYBENZONE 30 mg/g
  • OCTISALATE 50 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TALC (UNII: 7SEV7J4R1U)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL DIMETHICONE 45 (UNII: IK315POC44)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.
  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bio-medical & Pharmaceutical Manufacturing Corporation
Labeler Code: 37945
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-05-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pro-tect Sports Sunscreen Product Label Images

Pro-tect Sports Sunscreen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

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

Purpose

Sunscreen

Uses

• Pro-Tect® SPF 20+ Broad-Spectrum UVA & UVB protection. • Helps prevent sunburn. • Retains a SPF of 20+ after 80 minutes of activity in water or perspiring. • Provides high protection against sunburn and tanning. • For skin highly sensitive to sunburn.

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.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Directions

•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed. •Children under 6 months of age: ask a doctor.

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.

Other Information

• Daily usage of Pro-Tect® SPF 20+ may help reduce the chance of premature aging of the skin due to overexposure to the sun. • This product provides more than 20 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.

* Please review the disclaimer below.