NDC 65753-600 Coretex Sun X 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 65753-600

NDC 65753-600-01

Package Description: 30 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-02

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-03

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-04

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-05

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-07

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-08

Package Description: 473 mL in 1 BAG

NDC 65753-600-09

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-10

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-22

Package Description: 175 POUCH in 1 CONTAINER > 7 mL in 1 POUCH (65753-600-39)

NDC 65753-600-23

Package Description: 350 POUCH in 1 CONTAINER > 7 mL in 1 POUCH (65753-600-39)

NDC 65753-600-24

Package Description: 350 POUCH in 1 CONTAINER > 7 mL in 1 POUCH (65753-600-39)

NDC 65753-600-25

Package Description: 700 POUCH in 1 CONTAINER > 7 mL in 1 POUCH (65753-600-39)

NDC 65753-600-26

Package Description: 2100 POUCH in 1 CARTON > 7 mL in 1 POUCH (65753-600-39)

NDC 65753-600-32

Package Description: 44 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-33

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-34

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 65753-600-39

Package Description: 7 mL in 1 POUCH

NDC Product Information

Coretex Sun X 50 with NDC 65753-600 is a a human over the counter drug product labeled by Coretex Products. The generic name of Coretex Sun X 50 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Coretex Products

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.

Coretex Sun X 50 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 4 g/100mL
  • AVOBENZONE 2.4 g/100mL
  • HOMOSALATE 12 g/100mL
  • OCTOCRYLENE 4.8 g/100mL

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.

  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • WATER (UNII: 059QF0KO0R)
  • DICAPRYLYL ETHER (UNII: 77JZM5516Z)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
  • OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
  • GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Coretex Products
Labeler Code: 65753
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: 08-16-2019 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.

Coretex Sun X 50 Product Label Images

Coretex Sun X 50 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

AvobenzoneHomosalateOctisalateOctocrylene

Purpose

SunscreenSunscreenSunscreenSunscreen

Uses

  • Helps prevent sunburnif used as directed with other protection measures (see
  • Directions), decreases the 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 Center right away.

Directions

  • Apply generously and evenly 15 minutes before sun exposureSun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 am to 2 pmwear long-sleeved shirt, pants, hat and sunglassesreapplyafter 80 minutes of swimming or sweatingimmediately after towel dryingat least every two hoursChildren under 6 months of age: Ask a doctor.

Other Information

  • Protect the product from excessive heat and direct sun

Inactive Ingredients

Benzoic acid, caprylyl methicone, cetyl PEG/PPG-10-1 dimethicone, dicaprylyl ether, edetate disodium, ethylhexylglycerin,glycereth-2 cocoate, stearyl/octyldodecyl citrate crosspolymer, phenoxyethanol, propylene glycol, sodium chloride, water

Questions?

Call 1-877-684-5774

* Please review the disclaimer below.