NDC 73978-007 B.tan Sun Safe Af Spf 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 73978-007

NDC 73978-007-01

Package Description: 170 g in 1 BOTTLE, SPRAY

NDC Product Information

B.tan Sun Safe Af Spf 50 with NDC 73978-007 is a a human over the counter drug product labeled by Marque Of Brands Americas, Llc. The generic name of B.tan Sun Safe Af Spf 50 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is spray and is administered via topical form.

Labeler Name: Marque Of Brands Americas, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

B.tan Sun Safe Af Spf 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.

  • AVOBENZONE 3 g/100g
  • HOMOSALATE 15 g/100g
  • OCTISALATE 5 g/100g
  • OCTOCRYLENE 10 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • TRICAPRIN (UNII: O1PB8EU98M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
  • OCTYL ACRYLATE (UNII: EJN94319DN)

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: Marque Of Brands Americas, Llc
Labeler Code: 73978
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-17-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

B.tan Sun Safe Af Spf 50 Product Label Images

B.tan Sun Safe Af Spf 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

Otc - Active Ingredient

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Otc - Purpose

Sunscreen

Indications & Usage

  • 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 onlyFlammable - Do not use while smoking or near heat or flame.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product: Keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it • contents under pressure.

• Do not puncture or incinerate. Do not store at temperature above 120°F.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionsHold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well ventilated area. • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • children under 6 months: ask a doctor. • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF 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 shirts, pants, hats, and sunglasses.

Other Safety Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

Alcohol Denat., Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Glycerin, Fragrance (Parfum), Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Ascorbic Acid

Otc - Questions

Call 1800-914-3880

* Please review the disclaimer below.