NDC 72043-2600 Eltamd Uv Active

Zinc Oxide, Titanium Dioxide Sunscreen

NDC Product Code 72043-2600

NDC Product Information

Eltamd Uv Active with NDC 72043-2600 is a a human over the counter drug product labeled by Eltamd Skincare, Inc.. The generic name of Eltamd Uv Active is zinc oxide, titanium dioxide sunscreen. The product's dosage form is cream and is administered via topical form.

Labeler Name: Eltamd Skincare, Inc.

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.

Eltamd Uv Active 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 190 g/1000g
  • TITANIUM DIOXIDE 40 g/1000g

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)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • ALUMINUM SILICATE (UNII: T1FAD4SS2M)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • MALIC ACID (UNII: 817L1N4CKP)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • C15-19 ALKANE (UNII: CI87N1IM01)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)

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.
  • 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: Eltamd Skincare, Inc.
Labeler Code: 72043
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: 02-03-2020 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.

Eltamd Uv Active Product Label Images

Eltamd Uv Active 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

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask physician if rash occurs. When using this product keep out of eyes. Rinse with water to remove. If product is swallowed, get medical help or contact a Poison Control Center right away.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Active Ingredients

Zinc Oxide   19.0%   SunscreenTitanium Dioxide   4.0%   Sunscreen

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every two hours. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

Questions

Questions or Comments?1-800-633-8872

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, caprylic/capric trigylceride, coco-caprylate/caprate, ethyl macadamiate, glycerin, sorbitan olivate, polyglyceryl-6 polyricinoleate, C15-19 alkane, hydrogenated polyisobutene, sodium chloride, triethoxycaprylylsilane, silica, glyceryl beheanate, hydroxyacetophenone, polyglyceryl-2 isostearate, polyhydroxysearic acid, disteardimonium hectorite, 1,2-hexanediol, caprylyl glycol, hydrolyzed jojoba esters, xanthan gum, diemthicone, sclerotium gum, trisodium ethylenediamine disuccinate, lecithin, pullulan, jojoba esters, polygonum aviculare extract, tocopherol, malic acid

* Please review the disclaimer below.