NDC 71585-109 Mineral Sunscreen - Water Resistant Spf-50

Zinc Oxide

NDC Product Code 71585-109

NDC Code: 71585-109

Proprietary Name: Mineral Sunscreen - Water Resistant Spf-50 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Zinc Oxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71585 - Salt And Stone
    • 71585-109 - Mineral Sunscreen - Water Resistant

NDC 71585-109-21

Package Description: 88 mL in 1 TUBE

NDC Product Information

Mineral Sunscreen - Water Resistant Spf-50 with NDC 71585-109 is a a human over the counter drug product labeled by Salt And Stone. The generic name of Mineral Sunscreen - Water Resistant Spf-50 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Salt And Stone

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.

Mineral Sunscreen - Water Resistant Spf-50 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 22.8 g/100mL

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.

  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • ROSA CANINA SEED (UNII: 4503R1M9UT)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Salt And Stone
Labeler Code: 71585
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: 07-28-2019 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.

Mineral Sunscreen - Water Resistant Spf-50 Product Label Images

Mineral Sunscreen - Water Resistant Spf-50 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 22.8%

Purpose

SUNSCREEN

Use

  • HELPS PREVENT SUNBURN.If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skinaging caused by the sun.

Warnings

For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.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 HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

• Apply liberally 15 minutes before sun exposure• Reapply:• After 80 minutes of swimming or sweating• Immediately after towel drying• At least every 2 hours• Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & other sun protection measures including:• Limit time in the sun, especially from 10am - 2pm.• Wear long-sleeve shirts, pants, hats, and sunglasses.• Children under 6 months: Ask a doctor

Inactive Ingredients

Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Caprilic/capric triglyceride, Dimethicone, Octyl Palmitate, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Cera Alba (Beeswax), Glycerol, Polyethylene, Rosa Canina (Rosehip) Seed Oil, Persea Gratissima (Avocado) Oil, Hyaluronic Acid, Ethylhexylglycerin, Phenoxyethanol, Glyceryl Oleate, Xanthan gum.

Other Information

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

* Please review the disclaimer below.

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