NDC 72841-101 Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30

Zinc Oxide

NDC Product Code 72841-101

NDC Code: 72841-101

Proprietary Name: Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 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.


Code Structure
  • 72841 - Leiluna Llc
    • 72841-101 - Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30

NDC 72841-101-01

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC Product Information

Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 with NDC 72841-101 is a a human over the counter drug product labeled by Leiluna Llc. The generic name of Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Leiluna Llc

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.


Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 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 130 mg/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • WITCH HAZEL (UNII: 101I4J0U34)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • FYTIC ACID (UNII: 7IGF0S7R8I)

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: Leiluna Llc
Labeler Code: 72841
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: 05-01-2019 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.

Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 Product Label Images

Treeactiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum Spf 30 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

Distributed by: Leiluna LLC, Wilmington, DE 19807

Active Ingredient(S)

Zinc Oxide 13%

Purpose

Sunscreen

Use(S)

  • 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 and evenly 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.Sun Protections Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:limiting time in the sun especially from 10:00a.m. - 2:00 p.m.wear long-sleeve shirts, pants, hats, and sunglasses.Chidren under 6 months: Ask a doctor

Inactive Ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Polysorbate 60, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed OilCertified organic, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Sclerotium Gum, Caprylyl Glycol, Polyhydroxystearic Acid, Phytic Acid, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Citric Acid, Alcohol

Other Information

  • Protect this product from excessive heat and direct sun

* Please review the disclaimer below.

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