NDC 65692-0747 Natural Mineral Formula

Zinc Oxide

NDC Product Code 65692-0747

NDC 65692-0747-1

Package Description: 30 mL in 1 TUBE

NDC Product Information

Natural Mineral Formula with NDC 65692-0747 is a a human over the counter drug product labeled by Raining Rose, Inc.. The generic name of Natural Mineral Formula is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Raining Rose, Inc.

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.

Natural Mineral Formula 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.

  • ZINC OXIDE 5.625 g/30mL

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)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • JOJOBA OIL (UNII: 724GKU717M)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • 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: Raining Rose, Inc.
Labeler Code: 65692
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: 08-16-2019 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.

Natural Mineral Formula Product Label Images

Natural Mineral Formula 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

Other

DRUG FACTS

Otc - Active Ingredient

Active Ingredients: Zinc Oxide (18.75%) Non-nanoparticle

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • WarningsFor External Use Only

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - Stop Use

Stop use and as a doctor if • rash occurs

Otc - When Using

When using this product • Keep out of eyes.  Rinse well with water to remove.

Dosage & Administration

Directions •Apply liberally 15 minutes before sun exposure• Reapply after 80 minutes of swimming or sweating, •Reapply• immediately after towel drying. •Reapply at least every 2 hours• Children under 6 months of age: Ask a doctorSun Protection Measures Spending time in the sun increases yourrisk of skin cancer and early skin aging. To decrease this risk, regularlyuse a sunscreen with a Broad Spectrum SPF value of 15 or higher andother protection measures including:• limit time in the sun, especially from 10a.m. - 2p.m.• wear long sleeved shirts, pants, hat, and sunglasses.

Inactive Ingredient

Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*, Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*,non-GMO Tocopherol (Vitamin E). *Organic Ingredients

Other Safety Information

Other Information:  Protect this product from excessive heart and direct sun.

Product Package Labeling

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403Broad Spectrum SPF 30 SunscreenNATURAL MINERAL FORMULAWATER RESISTANT(80 MINUTES)1 fl. oz. / 30 mlMade in the USADist. by: Raining Rose Inc., Cedar Rapids, IA 52403L000000rege

* Please review the disclaimer below.