NDC 73978-009 B.tan Beach Please Spf 7

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 73978-009

NDC 73978-009-01

Package Description: 236 mL in 1 BOTTLE, SPRAY

NDC Product Information

B.tan Beach Please Spf 7 with NDC 73978-009 is a a human over the counter drug product labeled by Marque Of Brands Americas, Llc. The generic name of B.tan Beach Please Spf 7 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 Beach Please Spf 7 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/100mL
  • HOMOSALATE 6 g/100mL
  • OCTISALATE 5 g/100mL
  • OCTOCRYLENE 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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • TRICAPRIN (UNII: O1PB8EU98M)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • C13-15 ALKANE (UNII: 114P5I43UJ)

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 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: 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 Beach Please Spf 7 Product Label Images

B.tan Beach Please Spf 7 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 6%, Octisalate 5%, Octocrylene 8%

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 only

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.

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

  • DirectionsApple liberally 15 minutes before sun exposure.Reapply: after 80 minutes of swimming or sweatingImmediately after towel dryingAt least every 2 hoursChildren under 6 months of age: ask a doctor.Sun 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10am-2pmWear long-sleeved shirts, pants, hats and sunglasses.

Other Safety Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Silica, C13-14 Alkane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Vitis Vinifera (Grape) Seed Oil, Fragrance (Parfum), Argania Spinosa (Argan) Kernel Oil, Sclerocarya Birrea (Marula) Leaf Extract, Tocopheryl Acetate, Ascorbic Acid, Panthenol

Otc - Questions

Call 1800-914-3880

* Please review the disclaimer below.