NDC 73310-3022 Face And Body Spf 30

Avobenzone,octinoxate,octocrylene,oxybenzone,titanium Dioxide, Zinc Oxide

NDC Product Code 73310-3022

NDC 73310-3022-3

Package Description: 150 mL in 1 CONTAINER

NDC Product Information

Face And Body Spf 30 with NDC 73310-3022 is a a human over the counter drug product labeled by Agefarm Srl. The generic name of Face And Body Spf 30 is avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Agefarm Srl

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Face And Body 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.

  • OCTINOXATE 1 mg/5mL
  • OCTOCRYLENE 1 mg/5mL
  • OXYBENZONE 1 mg/5mL
  • ZINC OXIDE 1 mg/5mL
  • AVOBENZONE 1 mg/5mL
  • TITANIUM DIOXIDE 1 mg/5mL

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.

  • PEG-100 STEARATE (UNII: YD01N1999R)

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: Agefarm Srl
Labeler Code: 73310
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: 08-28-2019 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: 12-31-2020 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.

Face And Body 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

AVOBENZONEOCTINOXATEOCTOCRYLENEOXYBENZONEZINC OXIDETITANIUM DIOXIDE

Purpose

SUNSCREEN

Uses

Helps prevent sunburnuse 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 onlyDo not use damaged or broken skinStop use and ask doctor if rash occursWhen using this product, keep out of eyes. Rinse with water to removeKeep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposurereapply: at least every 2 hours, immediately after towel dryinguse a water-resistant sunscreen if swimming or sweatingchildren 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 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

Inactive Ingredients

Ammonium acryloydimethyltaurate vp copolymer, bixa orellana seed extract, benzyl alcohol, bis-ethylhexyloxyphenol methoxyphenyl triazine, caprylic-capric triglyceride, cetaryl alcohol, citronellol, coumarin, c12-15 alkyl benzoate, decyl glucose, diisopropyl sebacate, dimethicone, dimethiconol behenate, ethylhexlglycerin, glycerin, glyceryl stearate, hexyl cinnamal, hydrolyzed soy protein, hydrolyzed wheat protein, limonene, linalool, menthylene bis-benzotriazoyl tetramethybutyphenol (nano), parfum, peg-100 stearate, propylene glycol, menthyl lactate, silica, tocopheryl acetate, tocopherol, tripeptide-1, vp-eicosene copolymer, water, xanthan gum

Other Information

Protect this product from excessive heat and direct sun

Sunscreen Label

SUNSCREEN 22 SPF 30.jpg

* Please review the disclaimer below.