NDC 42406-035 Sugar Orchid Tinted Lip Treatment Sunscreen Spf15

Octinoxate

NDC Product Code 42406-035

NDC Code: 42406-035

Proprietary Name: Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 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: Octinoxate 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
  • 42406 - Fresh Inc.
    • 42406-035 - Sugar Orchid Tinted Lip Treatment Sunscreen Spf15

NDC 42406-035-00

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

NDC Product Information

Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 with NDC 42406-035 is a a human over the counter drug product labeled by Fresh Inc.. The generic name of Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 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 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.


Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 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.

  • OCTINOXATE 67.4 mg/g

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.

  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • JOJOBA OIL (UNII: 724GKU717M)
  • 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)
  • 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)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CITRAL (UNII: T7EU0O9VPP)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • GERANIOL (UNII: L837108USY)

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: Fresh Inc.
Labeler Code: 42406
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: 02-01-2019 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: 12-31-2019 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.

Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 Product Label Images

Sugar Orchid Tinted Lip Treatment Sunscreen Spf15 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 exposure


• Use a water resistant sunscreen if swimming or sweating


• Reapply at least every 2 hours


• Children under 6 months: Ask a doctor

Other Information

Protect this product in container from excessive heat and direct sun

Inactive Ingredients

Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, 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, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Polyglyceryl-3 Polyricinoleate, Ammonium Glycyrrhizate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol, [May Contain: CI 15850 (Red 6, Red 7, Red 7 Lake), CI 15985 (Yellow 6, Yellow 6 Lake), CI 19140 (Yellow 5, Yellow 5 Lake), CI 42090 (Blue 1 Lake), CI 45410 (Red 27, Red 27 Lake, Red 28 Lake), CI 77491, CI 77492, CI 77499 (Iron


Oxides), CI 77891 (Titanium Dioxide)] <12341/Z>

* Please review the disclaimer below.

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