NDC 23319-0053 Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena

Octinoxate

NDC Product Code 23319-0053

NDC CODE: 23319-0053

Proprietary Name: Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena What 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 What 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.

NDC Code Structure

  • 23319 - Yanbal Usa, Inc.
    • 23319-0053 - Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena

NDC 23319-0053-1

Package Description: 1 TUBE in 1 CARTON > 4 g in 1 TUBE

NDC Product Information

Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena with NDC 23319-0053 is a a human over the counter drug product labeled by Yanbal Usa, Inc.. The generic name of Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena is octinoxate. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Yanbal Usa, Inc.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.

Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena 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 40 mg/g

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: Yanbal Usa, Inc.
Labeler Code: 23319
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: 12-01-2019 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: 12-31-2020 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.

Yanbal Hydra-lip Labial Color Intenso Intense Color Sunscreen Spf 15 Sol De Arena 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 Ingredient

Octinoxate 4%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 prevent sunburn, not skin cancer or early skin aging.
For external use only.Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
Keep out of the 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 at least every 2 hourschildren under 6 months: Ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sunreport serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

ISOSTEARYL ISOSTEARATE, RICINUS COMMUNIS (CASTOR) SEED OIL, BIS-PEG-12 DIMETHICONE BEESWAX, CANDELILLA CERA / EUPHORBIA CERIFERA (CANDELILLA) WAX, POLYETHYLENE, BUTYLOCTYL SALICYLATE, HYDROGENATED POLYISOBUTENE, C10-30 CHOLESTEROL / LANOSTEROL ESTERS, HYDROGENATED POLYDECENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, AQUA / WATER, POLYGLYCERYL-10 HEPTAHYDROXYSTEARATE, CERA MICROCRISTALLINA / MICROCRYSTALLINE WAX, CETYL ALCOHOL, POLYAMIDE-5, CAPRYLYL GLYCOL, TOCOPHEROL, PARFUM / FRAGRANCE, PHENOXYETHANOL, OLIVE GLYCERIDES, ISOCETYL STEAROYL STEARATE, HEXYLENE GLYCOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, GLYCERIN, MYRICA PUBESCENS FRUIT WAX, HEXYL CINNAMIC ALDEHYDE, BENZYL SALICYLATE, LINALOOL, CITRONELLOL, HYDROXYCITRONELLAL, GERANIOL, CERAMIDE-3, BENZYL BENZOATE, LIMONENE, BENZYL CINNAMATE, BHT, ALPHA-ISOMETHYL IONONE, SYNTHETIC FLUORPHLOGOPITE, TIN OXIDE, MICA, TITANIUM DIOXIDE (CI 77891), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 30 LAKE (CI 73360), IRON OXIDES (CI 77491), RED 7 LAKE (CI 15850), YELLOW 5 LAKE (CI 19140), RED 33 LAKE (CI 17200), MANGANESE VIOLET (CI 77742), YELLOW 10 LAKE (CI 47005), IRON OXIDES (CI 77499), IRON OXIDES (CI 77492), BLUE 1 LAKE (CI 42090), BRONZE POWDER (CI 77400), CARMINE (CI 75470), BISMUTH OXYCHLORIDE (CI 77163), RED 40 LAKE (CI 16035).

Company Information

Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

Product Packaging - Ambre

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Burdeo Night

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Chocolat

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Creme Nude

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Dusty Red

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Guinda Etnico

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Honey Nude

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Lady Malbec

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Orquidea Pink

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Rosa Toscana

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Sugar Pop

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Summer Nude

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Terciopelo Negro

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Tierra De Rosas

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Velvet Rose

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - West Malva

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Berry Wine

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Bronz

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Classic Red

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Hot Summer

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Native Nude

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Solarium

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Tentacion

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Arena Dorada

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Fuego Colorado

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

Product Packaging - Ultra Red

YANBALHYDRA-LIP LABIAL COLOR INTENSOINTENSE COLOR LIPSTICKSUNSCREEN SPF 15Net wt. 4 g 0.14 oz

* Please review the disclaimer below.