NDC 42406-050 Sugar Lip Treatment Sunscreen Spf 15

Octinoxate

NDC Product Code 42406-050

NDC 42406-050-02

Package Description: 1 TUBE in 1 BOX > 2.2 g in 1 TUBE

NDC 42406-050-04

Package Description: 1 TUBE in 1 BOX > 4.3 g in 1 TUBE

NDC Product Information

Sugar Lip Treatment Sunscreen Spf 15 with NDC 42406-050 is a a human over the counter drug product labeled by Fresh, Inc.. The generic name of Sugar Lip Treatment Sunscreen Spf 15 is octinoxate. The product's dosage form is paste and is administered via topical form.

Labeler Name: Fresh, Inc.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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.

Sugar Lip Treatment Sunscreen Spf 15 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.

  • OCTINOXATE 67.4 mg/g

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.

  • CASTOR OIL (UNII: D5340Y2I9G)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
  • PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
  • SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
  • LEMON OIL (UNII: I9GRO824LL)
  • RIBES NIGRUM SEED OIL (UNII: GKE1188837)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • VANILLIN (UNII: CHI530446X)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CITRAL (UNII: T7EU0O9VPP)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Fresh, Inc.
Labeler Code: 42406
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: 04-01-2019 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: 12-31-2021 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 - 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sugar Lip Treatment Sunscreen Spf 15 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

Octinoxate 6.74%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctor

Other Information

Protect this product in container from excessive heat and direct sun

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Hydrogenated Olive Oil Decyl Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Citrus Limon (Lemon) Peel Oil, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Vanillin, BHT, Limonene, Citral, Linalool, Benzyl Alcohol <12958/Z>

* Please review the disclaimer below.