NDC 71398-012 Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen

Titanium Dioxide And Zinc Oxide

NDC Product Code 71398-012

NDC Code: 71398-012

Proprietary Name: Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen 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: Titanium Dioxide And 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

  • 71398 - Sent�, Inc.
    • 71398-012 - Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen

NDC 71398-012-01

Package Description: 1 TUBE in 1 CARTON > 52 g in 1 TUBE

NDC Product Information

Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen with NDC 71398-012 is a a human over the counter drug product labeled by Sent�, Inc.. The generic name of Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen is titanium dioxide and zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Sent�, 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.

Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen 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.

  • TITANIUM DIOXIDE 57.5 mg/g
  • ZINC OXIDE 111.5 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.

  • WATER (UNII: 059QF0KO0R)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • STEARETH-2 (UNII: V56DFE46J5)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • STEARETH-21 (UNII: 53J3F32P58)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • CICHORIUM INTYBUS (CHICORY) ROOT OLIGOSACCHARIDES (UNII: 38AFY41EAR)
  • BATILOL (UNII: 39YR661C4U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Sent�, Inc.
Labeler Code: 71398
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: 05-15-2019 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’.

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Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen Product Label Images

Invisible Shield Full Physical Tinted Spf 52 Broad Spectrum Sunscreen 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 - Purpose

Active ingredientsPurpose  Titanium Dioxide 5.75%SunscreenZinc Oxide 11.15%Sunscreen

Uses

  • Helps prevent sunburnIf 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 rash 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 liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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.Children under 6 months of age: Ask a doctor

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Caprylyl Methicone, Acetamidoethoxyethanol, Steareth-2, Polyhydroxystearic Acid, Steareth-21, Glycerin, Biosaccharide Gum-4, Fructose, Withania Somnifera Root Extract, Yeast Extract, Hydrolyzed Candida Saitoana Extract, Cichorium Intybus (Chicory) Root Extract, Batyl Alcohol, Stearic Acid, Alumina, Triethoxycaprylylsilane, Xanthan Gum, Phytic Acid, Sodium Hydroxide, Propanediol, Caprylyl Glycol, Caprylhydroxamic Acid, 1,2-Hexanediol, Disodium EDTA, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other Information

Protect the product in this container from excessive heat and direct sun

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