NDC 43219-052 Fre Protect Body Broad Spectrum Spf30

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 43219-052

NDC Code: 43219-052

Proprietary Name: Fre Protect Body Broad Spectrum Spf30 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: Avobenzone, Homosalate, Octisalate, Octocrylene 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

  • 43219 - Emilia Cosmetics Ltd
    • 43219-052 - Fre Protect Body Broad Spectrum Spf30

NDC 43219-052-05

Package Description: 150 mL in 1 TUBE

NDC Product Information

Fre Protect Body Broad Spectrum Spf30 with NDC 43219-052 is a a human over the counter drug product labeled by Emilia Cosmetics Ltd. The generic name of Fre Protect Body Broad Spectrum Spf30 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Emilia Cosmetics Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Fre Protect Body Broad Spectrum Spf30 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.

  • AVOBENZONE 30 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 100 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • STARCH, RICE (UNII: 4DGK8B7I3S)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ISOMALT (UNII: S870P55O2W)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Emilia Cosmetics Ltd
Labeler Code: 43219
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: 05-15-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fre Protect Body Broad Spectrum Spf30 Product Label Images

Fre Protect Body Broad Spectrum Spf30 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

Acitve Ingredients

Avobenzone, 3%Homosalate, 10%Octisalate, 5%Octocrylene, 10%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see
  • Directions), decreases risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do Not Use On

Damaged or broken skin.

When Using This Product

  • Keep out of eyes. Rinse with water to remove.

Stop Use, And Ask A Doctor

If rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hours.use water resistant sunscreen if swimming or sweating, children under 6 months of age: ask a doctorSun 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 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 shits, pants, hats and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Water, propanediol, coco-caprylate, diethylhexyl 2,6-naphthalate C12-15 alkyl benzoate, oryza sativa (rice) starch, phenoxyethanol, ethylhexylglycerin, tricontanyl PVP, glycerin, argania spinosa leaf extract, aloe barbadensis leaf juice, polyglyceryl-10 pentastearate, behenyl alcohol, sodium stearoyl lactylate, potassium cetyl phosphate, fragrace, xanthan gum, acrylate/C10-30 alkyl acrylate crosspolymer, allantoin, tocopheryl acetate (vitamin E), argania spinosa kernel oil, sodium phytate, butylene glycol, pentylene glycol, hydroxyphenyl propamidobenzoic acid, panthenol (pro-vitamin B5), sodium hydroxide, argania spinosa sprout cell extract, isomalt, lecithin, sodium benzoate.

* Please review the disclaimer below.