NDC 77714-002 Bull Frog Spf 50

Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00%

NDC Product Code 77714-002

NDC 77714-002-48

Package Description: 148 mL in 1 BOTTLE

NDC Product Information

Bull Frog Spf 50 with NDC 77714-002 is a a human over the counter drug product labeled by Bullfrog Brands, Llc. The generic name of Bull Frog Spf 50 is avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00%. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Bull Frog 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.


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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • PHENETHYL BENZOATE (UNII: 0C143929GK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • PPG-12 (UNII: L63N6V755Z)
  • ROSEMARY (UNII: IJ67X351P9)

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: Bullfrog Brands, Llc
Labeler Code: 77714
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: 08-08-2021 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.

Bull Frog Spf 50 Product Label Images

Bull Frog 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 - Purpose

Sunscreen

Indications & Usage

Uses • helps prevent sunburn • 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.

Dosage & Administration

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 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 a.m.-2 p.m. • wear long-sleeved

shirts, pants, hats, and sunglasses. • Hold container 4 to 6 inches

from the skin to apply. • 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. • For sunscreen use: • apply to all

skin exposed to the sun. • Reapply as needed or after towel

drying, swimming, or sweating.

Inactive Ingredient

Inactive Ingredients:
Acacia Famesiana extract, acrylate/octyl acrylamide copolymer, aloe barbadensis leaf extract, camellia sinensis leaf extract, chamomile flower extract, cyclohexasiloxane, cyclopentasiloxane, ethylhexyl palmitate, fragrance, glycerin, hydroxypropyl cellulose, isopropyl myrsitate, lavender extract, phenethyl benzoate, PPG-12 copolymer, propylene glycol, rosemary leaf extract, SD Alcohol 40, Tocopheryl (Vitamin E) Acetate.

* Please review the disclaimer below.