NDC 65753-500 Sunx Spf 30/bugx Wallmount

Sunx Spf 30/bugx Wallmount

NDC Product Code 65753-500

NDC 65753-500-24

Package Description: 1 KIT in 1 KIT * 7 mL in 1 POUCH (65753-101-10)

NDC Product Information

Sunx Spf 30/bugx Wallmount with NDC 65753-500 is a a human over the counter drug product labeled by Coretex Products. The generic name of Sunx Spf 30/bugx Wallmount is sunx spf 30/bugx wallmount. The product's dosage form is kit and is administered via form.

Labeler Name: Coretex Products

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • NASTURTIUM OFFICINALE (UNII: YH89GMV676)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • COMFREY LEAF (UNII: DG4F8T839X)
  • EDETIC ACID (UNII: 9G34HU7RV0)

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
Marketing Category: UNAPPROVED DRUG OTHER - 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: 11-22-2019 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.

Sunx Spf 30/bugx Wallmount 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

Avobenzone 1.0%Homosalate 5.0%Octinoxate 7.5%Octisalate 5.0%Oxybenzone 6.0%

Purpose

SunscreenSunscreenSunscreenSunscreenSunscreen

Uses

Helps prevent sunburnIf used as directed with other sun 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 the eyesrinse with water to remove

Stop Use And Ask A Doctor

  • If rash occurs

Keep Out Of The Reach Of Children

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

Directions

  • Apply liberally 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 this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and after sun protection measures including:
  • Limit time in the sun, especially from 10:00 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats and sunglasses. reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months of age: Ask a doctor

Other Information

  • Protect this product from excessive heat or direct sun

Inactive Ingredients

Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide, ethylparaben, fragrance, glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

Questions?

Call: 1-877-684-5774

Sunx/Bugx Kit Contents

50 count- SunX SPF 30, BugX 30

* Please review the disclaimer below.