NDC 73025-070 30 Spf Jack Nicklaus

Sunscreen

NDC Product Code 73025-070

NDC 73025-070-01

Package Description: 159 g in 1 CAN

NDC Product Information

30 Spf Jack Nicklaus with NDC 73025-070 is a a human over the counter drug product labeled by Shalom International Corp. The generic name of 30 Spf Jack Nicklaus is sunscreen. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Shalom International Corp

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

30 Spf Jack Nicklaus 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 2 g/100g
  • HOMOSALATE 15 g/100g
  • OCTISALATE 5 g/100g
  • OXYBENZONE 4 g/100g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
  • ALCOHOL (UNII: 3K9958V90M)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MINERAL OIL (UNII: T5L8T28FGP)

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.
  • 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: Shalom International Corp
Labeler Code: 73025
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: 07-08-2020 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 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.

30 Spf Jack Nicklaus Product Label Images

30 Spf Jack Nicklaus 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 (W/W )

Avobenzone 2%Homosalate 15%Octisalate 5%Oxybenzone 4%

Purpose

Sunscreen

Use

Helps prevent sunburn. If used as directed with other skin protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.Do not place in hot water or near radiator, stove or other sources of heat.Do not puncture or incinerate container or store at temperature above 50°C. Contents under pressure.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults, adolescents and children over 6 months of age •Spray generously and spread evenly by hand 15 minutes before sun exposure.Hold container 4 to 6 inches from skin to apply. • Do not spray directly onto face. Spray on hands, thenapply to face.Do not apply in windy conditions • Use in a well-ventilated area. •Avoid inhaling or exposing others to spray.Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 am - 2 pmwear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun  • Store at room temperature 59-86°F. May stain surfaces and fabrics.

Inactive Ingredients

Acrylates/ Octylacrylamide Copolymer, Alcohol Denat., Aloe Barbadensis Leaf Juice, Cocos Nucifera (coconut) oil, Diethylhexyl 2,6- Naphthalate, Glycerin, Mineral Oil, Fragrance (Parfum).

Questions?

1-866-923-2665Manufactured in Canada by/ Fabriqué au Canada par: Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6UPC Please recycle (+ logo) Lot # and Expiry Date jet printed on the bottom of the aerosol can

* Please review the disclaimer below.