NDC 0023-5675 Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen
Titanium Dioxide And Zinc Oxide Lotion Topical

Product Information

What is NDC 0023-5675?

The NDC code 0023-5675 is assigned by the FDA to the UNFINISHED product Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen which is a human over the counter drug product labeled by Allergan, Inc.. The generic name of Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen is titanium dioxide and zinc oxide. The product's dosage form is lotion and is administered via topical form. The product is distributed in 4 packages with assigned NDC codes 0023-5675-08 1 bottle in 1 carton / 227 g in 1 bottle, 0023-5675-13 12 tube in 1 carton / 3.68 g in 1 tube, 0023-5675-17 1 tube in 1 carton / 52.5 g in 1 tube, 0023-5675-25 6 tube in 1 carton / 7.1 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0023-5675
Proprietary Name 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.		Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen
Non-Proprietary Name 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.		Titanium Dioxide And Zinc Oxide
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Titanium Dioxide; Zinc Oxide
Product Type 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.		Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.		Allergan, Inc.
Labeler Code0023
FDA Application Number 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.		part352
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-16-2016
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

What are the uses for Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen?


Product Packages

NDC Code 0023-5675-08

Package Description: 1 BOTTLE in 1 CARTON / 227 g in 1 BOTTLE

NDC Code 0023-5675-13

Package Description: 12 TUBE in 1 CARTON / 3.68 g in 1 TUBE

NDC Code 0023-5675-17

Package Description: 1 TUBE in 1 CARTON / 52.5 g in 1 TUBE

NDC Code 0023-5675-25

Package Description: 6 TUBE in 1 CARTON / 7.1 g in 1 TUBE

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen Active Ingredients UNII Codes

Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Active Ingredients



Titanium Dioxide 5.0%

Zinc Oxide 6.0%


Purpose



Sunscreen

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


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 skin 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
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing
  • Children under 6 months: Ask a doctor

Inactive Ingredients



Water, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Dimethicone/PEG-10/15 Cross polymer, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Caffeine, Camellia Oleifera Leaf Extract, Tocopheryl Acetate, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethoxvsilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Stearic Acid, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)


Other Information



  • Protect this product from excessive heat and direct sun
  • Store at room temperature 15° - 30°C (59° - 86°F)

Questions Or Comments?



www.skinmedica.com


Principal Display Panel - Carton Label



SkinMedica®

ESSENTIAL
DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST PROCEDURE &

SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g


Principal Display Panel - Tube Label



SkinMedica®

ESSENTIAL
DEFENSE

MINERAL SHIELD™

BROAD SPECTRUM

SPF 32

SUNSCREEN

POST-PROCEDURE &
SENSITIVE SKIN

TINTED

SUN PROTECTION

Net Wt. 1.85 Oz. / 52.5 g


* Please review the disclaimer below.