NDC 79287-0000 Larkly Spf30 Mineral Powder Face Sunscreen

Titanium Dioxide And Zinc Oxide

NDC Product Code 79287-0000

NDC 79287-0000-2

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > .006 kg in 1 BOTTLE, WITH APPLICATOR (79287-0000-1)

NDC 79287-0000-4

Package Description: 1 JAR in 1 BOX > .006 kg in 1 JAR (79287-0000-3)

NDC Product Information

Larkly Spf30 Mineral Powder Face Sunscreen with NDC 79287-0000 is a a human over the counter drug product labeled by Larkly, Llc. The generic name of Larkly Spf30 Mineral Powder Face Sunscreen is titanium dioxide and zinc oxide. The product's dosage form is powder and is administered via topical form.

Labeler Name: Larkly, Llc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Larkly Spf30 Mineral Powder Face 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 .212 kg/kg
  • ZINC OXIDE .15 kg/kg

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.

  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CERAMIDE 1 (UNII: 5THT33P7X7)
  • CERAMIDE 2 (UNII: C04977SRJ5)
  • CERAMIDE 3 (UNII: 4370DF050B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HEXAMETHYLDISILAZANE (UNII: H36C68P1BH)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)
  • MICA (UNII: V8A1AW0880)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • RESVERATROL (UNII: Q369O8926L)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)

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: Larkly, Llc
Labeler Code: 79287
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: 07-10-2020 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.

Larkly Spf30 Mineral Powder Face 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

Drug Facts

Active Ingredient...........................PurposeTitanium Dioxide 21.00%..................SunscreenZinc Oxide 15.00%..........................Sunscreen

Uses

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or borken 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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally 15 minutes before sun exposurereapply:   after 80 minutes of swimming or sweatingimmediately after towel drying at least every 2 hourschildren under 6 months: Ask a doctor

Inactive Ingredients

Alpha-Tocopherol, Caprylic/Capric Triglyceride, Capryloyl Glycerin, Ceramide I, Ceramide II, Ceramide III, Ethylhexylglycerin, Fumed Silica, Glycyrrhiza Glabra, Green Tea Leaf, Iron Oxide Black, Iron Oxide Red, Iron Oxide Yellow, Kaolin, Magnesium Hydroxide, Maranta Arundinacea Root, Mica, Glyceryl Caprylate, Glycerin, Caprylhydroxamic Acid, Resveratol, Sebacic Acid Copolymer, Tapioca Starch

* Please review the disclaimer below.