NDC 72812-145 Earth Mama Mineral Sunscreen Spf 25

Zinc Oxide

NDC Product Code 72812-145

NDC Product Information

Earth Mama Mineral Sunscreen Spf 25 with NDC 72812-145 is a a human over the counter drug product labeled by Earth Mama Angel Baby, Llc. The generic name of Earth Mama Mineral Sunscreen Spf 25 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Earth Mama Angel Baby, Llc

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.

Earth Mama Mineral Sunscreen Spf 25 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 200 mg/g

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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • JOJOBA OIL (UNII: 724GKU717M)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • ROSA CANINA SEED (UNII: 4503R1M9UT)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

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: Earth Mama Angel Baby, Llc
Labeler Code: 72812
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: 04-01-2019 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: 12-31-2021 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.

Earth Mama Mineral Sunscreen Spf 25 Product Label Images

Earth Mama Mineral Sunscreen Spf 25 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

Drug Facts

Active Ingredient Zinc Oxide 20%

Otc - Purpose

Purpose Sunscreen

Indications & Usage

  • UsesHelps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases 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.

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 product is swallowed, get medical helpor contact Poison Control Center right away.

Dosage & Administration

  • Directions Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposureChildren under 6 months of age: 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 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 Reapplyafter 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours

Storage And Handling

  • Other Information Protect the product in this container from exessive heat and direct sun.

Inactive Ingredient

Inactive Ingredients Cocos Nucifera(Coconut) Oil*, Cocos nucifera (FractionatedCoconut) Oil*, Cera Alba (Beeswax)*, Helianthus Annus (Sunflower) Seed Oil*,Olea Europaea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii(Shea) Butter*, Tocopherol, Rubus Idaeus (Red Raspberry) Seed Oil*,Argania Spinosa (Argan) Kernel Oil*,Rosa Canina (Rosehip) Seed Oil*, Calendula Officinalis (Calendula) Flower Extract**Organic

Otc - Questions

Questions or comments? 503-607-0607  or earthmamaorganics.com

* Please review the disclaimer below.