NDC 73609-220 Seven Minerals Skin Friendly Spf 30

Avobenzone, Octisalate, Octocrylene

NDC Product Code 73609-220

NDC CODE: 73609-220

Proprietary Name: Seven Minerals Skin Friendly Spf 30 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, 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

  • 73609 - Seven Minerals Na Llc
    • 73609-220 - Seven Minerals Skin Friendly Spf 30

NDC 73609-220-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Seven Minerals Skin Friendly Spf 30 with NDC 73609-220 is a a human over the counter drug product labeled by Seven Minerals Na Llc. The generic name of Seven Minerals Skin Friendly Spf 30 is avobenzone, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Seven Minerals Na Llc

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.

Seven Minerals Skin Friendly Spf 30 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
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 50 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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • WATERMELON (UNII: 231473QB6R)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CARROT (UNII: L56Z1JK48B)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • MANGO (UNII: I629I3NR86)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CORN (UNII: 0N8672707O)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Seven Minerals Na Llc
Labeler Code: 73609
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: 02-03-2020 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.

Seven Minerals Skin Friendly Spf 30 Product Label Images

Seven Minerals Skin Friendly Spf 30 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 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • If 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 eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • If rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

  • If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.





SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: • Limit time in the sun, especially between 10am and 2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

Other Information:

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients:

Acrylates Copolymer, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Amodimethicone, Aqua (Deionized Water), Bis Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Butter, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Zemea (Corn) Propanediol.

* Please review the disclaimer below.