NDC 69219-109 Liprotect Spf 35

Zinc Oxide, Titanium Dioxide

NDC Product Code 69219-109

NDC 69219-109-01

Package Description: 5 g in 1 BOTTLE, PLASTIC

NDC 69219-109-11

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 5 g in 1 BOTTLE, PLASTIC (69219-109-01)

NDC Product Information

Liprotect Spf 35 with NDC 69219-109 is a a human over the counter drug product labeled by Science Of Skincare. The generic name of Liprotect Spf 35 is zinc oxide, titanium dioxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Science Of Skincare

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Liprotect Spf 35 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 10.2 g/100g
  • TITANIUM DIOXIDE 1 g/100g

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.

  • EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
  • REBAUDIOSIDE A (UNII: B3FUD0528F)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • SOY STEROL (UNII: PL360EPO9J)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • CERESIN (UNII: Q1LS2UJO3A)
  • CHERRY (UNII: BUC5I9595W)
  • EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • JOJOBA OIL (UNII: 724GKU717M)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CORN OIL (UNII: 8470G57WFM)
  • COCONUT OIL (UNII: Q9L0O73W7L)

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: Science Of Skincare
Labeler Code: 69219
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: 03-02-2021 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: 12-31-2022 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 - NO 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.

Liprotect Spf 35 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

Otc - Active Ingredient

Zinc Oxide 10.2%Titanium Dioxide 1.0%

Otc - Purpose

Sunscreen

Indications & Usage

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 And Precautions

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.

Dosage & Administration

Apply liberally 15 minutes before sun exposureUse a water resistance sunscreen if swimming or sweating.Reapply at least every 2 hoursSun 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 board spectrum SPF of 15 or higher and other sun protection measures including: limit time in sun, especially from 10am to 2pm. wear long-sleeve shirts, pants, hats, and sunglasses. Children under the age of 6 months. Ask a doctor.

Other Safety Information

Protect this product from excessive heat and direct sun.Store at 20-25C (68 - 77F)

Otc - Questions

Call Customer Care at (888) 804 - 4447

Inactive Ingredient

Vegetable Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Flavor(Aroma), C12-15 Alkyl Benzoate, Ozokerite, Hydrogenated Vegetable Oil, Sambucus Nigra Fruit Extract, Tocopherol, VP/Eicosene Copolymer, Caprylic/Capric Triglyceride, Dipalmitoyl Hydroxyproline, Simmondsia Chinensis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Polyhydroxystearic Acid, Ethylhexyl Palmitate, Rebaudioside A, Aluminum Stearate, Tribehenin, Palmitoyl Tripeptide-1, Linoleic Acid, Isostearic Acid, Glycine Soja (Soybean) Sterols, Phospholipids, Sorbitan Isostearate, Alumina.

* Please review the disclaimer below.