NDC 82052-157 Annmarie Spf 20 Sunscreen

Zinc Oxide 15%

NDC Product Code 82052-157

NDC 82052-157-01

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC Product Information

Annmarie Spf 20 Sunscreen with NDC 82052-157 is a a human over the counter drug product labeled by Annmarie Gianni Skin Care Llc. The generic name of Annmarie Spf 20 Sunscreen is zinc oxide 15%. The product's dosage form is lotion and is administered via topical form.

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.

Annmarie Spf 20 Sunscreen 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.

  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Annmarie Gianni Skin Care Llc
Labeler Code: 82052
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: 09-20-2021 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.

Annmarie Spf 20 Sunscreen Product Label Images

Annmarie Spf 20 Sunscreen 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

Zinc Oxide 15%

Purpose

Sunscreen

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.

Warnings

For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure. Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 value of 15 or higher and other sun protection measure including:
  • Limit time in the sun, especially from 10 am to 2 pmwear long-sleeved shirts, pants, hats, and sunglasses.Children under 6 months: ask a doctor.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Sorbitan Olivate, Cannabis Sativa Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Beeswax*, Lavandula Angustifolia (Lavender) Oil, Persea Gratissima (Avocado) Oil*, Mauritia Flexuosa Fruit Oil, Tocopherol. *Organic

* Please review the disclaimer below.