NDC 15751-3040 Lilikoi Mineral Defense Sport Sunscreen Spf 30

Zinc Oxide

NDC Product Code 15751-3040

NDC Code: 15751-3040

Proprietary Name: Lilikoi Mineral Defense Sport Sunscreen Spf 30 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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
  • 15751 - Eminence Organic Skin Care Ltd.
    • 15751-3040 - Lilikoi Mineral Defense Sport Sunscreen Spf 30

NDC 15751-3040-5

Package Description: 1 TUBE in 1 BOX > 147 mL in 1 TUBE

NDC Product Information

Lilikoi Mineral Defense Sport Sunscreen Spf 30 with NDC 15751-3040 is a a human over the counter drug product labeled by Eminence Organic Skin Care Ltd.. The generic name of Lilikoi Mineral Defense Sport Sunscreen Spf 30 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Eminence Organic Skin Care Ltd.

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 Additional informationCallout TooltipWhat 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.


Lilikoi Mineral Defense Sport Sunscreen Spf 30 Active Ingredient(s)

Additional informationCallout TooltipWhat 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 200 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALOE (UNII: V5VD430YW9)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • VANILLA (UNII: Q74T35078H)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • PAPAYA (UNII: KU94FIY6JB)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • ACAI (UNII: 46AM2VJ0AW)
  • LEMON (UNII: 24RS0A988O)
  • CARROT (UNII: L56Z1JK48B)
  • COCONUT (UNII: 3RT3536DHY)
  • WATER (UNII: 059QF0KO0R)
  • THIOCTIC ACID (UNII: 73Y7P0K73Y)
  • UBIDECARENONE (UNII: EJ27X76M46)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eminence Organic Skin Care Ltd.
Labeler Code: 15751
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Lilikoi Mineral Defense Sport Sunscreen Spf 30 Product Label Images

Lilikoi Mineral Defense Sport Sunscreen 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

Active Ingredients

Zinc Oxide 20%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by sun

Warnings

For external use only

Do Not Use

  • On damaged or broken skin

When Using This Product

  • Keep out of eyes. Rinse with water to remove

Stop Use And Ask A Doctor If

  • Rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursReapply after 40 minutes of swimming or sweating and immediately after towel drying.Sun 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 sunglassesChildren under 6 months of age: Ask a doctor

Other Information

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

Inactive Ingredients

Organic Phytonutrient Blend [(Tilia Cordata (Linden) Flower Tea, Aloe Barbadensis (Aloe) Juice, Camellia Sinensis (Green Tea) Leaf Extract, Vanilla Planifolia (Vanilla) Seed Extract and Soy Lecithin, Coco-Caprylate, Stearyl/Octyldodecyl Citrate Crosspolymer, Cetearyl Olivate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Passiflora Edulis (Passion Fruit) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Hippohae Rhamnoides (Seabuckthorn) Oil, Carica Papaya (Papaya) Fruit Extract, Cetearyl Alcohol, Panthenol (Provitamin B5), Lauroyl Lysine, Polyhydorxystearic Acid, Benzyl Alcohol, Dehydroacetic Acid, Xanthan Gum, Sodium Phytate, Biocomplex2 (Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut), Water, Lycium Barbarum (Goji) Berry, Tapioca Starch From Cassava Root, Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)].


Cerified organic ingredient.

* Please review the disclaimer below.

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