NDC 80449-300 Sweat Mineral Foundation Spf 30 Shade 300

Zinc Oxide

NDC Product Code 80449-300

NDC 80449-300-01

Package Description: 1 CONTAINER in 1 BOX > 2.7 g in 1 CONTAINER

NDC 80449-300-02

Package Description: 1 CONTAINER in 1 BOX > 2.7 g in 1 CONTAINER

NDC 80449-300-03

Package Description: 1 JAR in 1 BOX > 12 g in 1 JAR

NDC Product Information

Sweat Mineral Foundation Spf 30 Shade 300 with NDC 80449-300 is a a human over the counter drug product labeled by Sweat Cosmetics, Inc.. The generic name of Sweat Mineral Foundation Spf 30 Shade 300 is zinc oxide. The product's dosage form is powder and is administered via topical form.

Labeler Name: Sweat Cosmetics, Inc.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Sweat Mineral Foundation Spf 30 Shade 300 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 16 g/100g

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.

  • MICA (UNII: V8A1AW0880)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • SQUALANE (UNII: GW89575KF9)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • MILK THISTLE (UNII: U946SH95EE)
  • SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • SQUALANE (UNII: GW89575KF9)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • MILK THISTLE (UNII: U946SH95EE)
  • SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • SQUALANE (UNII: GW89575KF9)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • MILK THISTLE (UNII: U946SH95EE)
  • SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Sweat Cosmetics, Inc.
Labeler Code: 80449
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: 06-08-2015 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 - 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.

Sweat Mineral Foundation Spf 30 Shade 300 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

Dist. by Sweat Cosmetics, Inc. | Denver, CO 80210

Active Ingredients

Zinc Oxide 16%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and uniformly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, or at least every 2 hours. Children under 6 months of age: ask a doctor. Avoid inhaling while applying the product.

Other Information

Protect the product in this container from excessive heat or direct sun.

Inactive Ingredients

  • Mica, Boron Nitride, Squalane, Silica, Bismuth Oxychloride, Caprylyl Glycol, Tocopherol, Phenoxyethanol, Lecithin, Isopentyldiol, Silybum Marianum Seed Extract, Rhodiola Rosea Root Extract, Propanediol, WaterMay Contain: Titanium Dioxide (Cl 77891), Iron Oxides (Cl 77491, Cl 77492, Cl 77499)

* Please review the disclaimer below.