NDC 72878-2530 Sahi Cosmetics

Sahi Cosmetics Skin Perfecting Elixir Foundation

NDC Product Code 72878-2530

NDC 72878-2530-1

Package Description: 1 BOTTLE, PUMP in 1 BOX > 30 mL in 1 BOTTLE, PUMP

NDC Product Information

Sahi Cosmetics with NDC 72878-2530 is a a human over the counter drug product labeled by Sahi Cosmetics L.l.c.. The generic name of Sahi Cosmetics is sahi cosmetics skin perfecting elixir foundation. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Sahi Cosmetics L.l.c.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.


Sahi Cosmetics 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.

  • OCTOCRYLENE 2.5 g/.025mL
  • OCTINOXATE 2.5 g/.025mL

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.

  • WATER (UNII: 059QF0KO0R)

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: Sahi Cosmetics L.l.c.
Labeler Code: 72878
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: 03-01-2019 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.

Sahi Cosmetics Product Label Images

Sahi Cosmetics 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

Drug Facts Active Ingredients.PurposeDrug Facts (continued) Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Octocrylene 2.5% Sunscreen

Ethyl Methoxycinnamate 2.5%
(octinoxate) Sunscreen

Use helps prevent sunburn
WarningsFor external use onlyLimit time in the sun, especially from 10 a.m. – 2 p.m.Wear long-sleeved shirts, pants, hats, and sunglassesDo not useChildren under 6 months of age: askadoctor.on damaged or brokenWhen using this product keepout of eyes. Rinse with water to remove.Stop use and ask a doctor if too much skin irritation or sensitivity develops or increasesKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.DirectionsFor sunscreen use:

apply liberally 15 minutes before sun
skinexposure.

reapply every two hours

use a water resistant sunscreen if swimming or sweating.
Inactive IngredientsDEIONIZED WATER, ALCOHOL,

P O L Y M E T H Y L S I L S E S Q UI O X A N E ,

T RIMET HYLSILOXYSILIC A TE, CYCLOPENT ASILOXANE, DIMETHICONE,GLYCERINE, STEARYL DIMETHICONE (AND) OCT ADECENE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, TOCOPHERYL ACET ATE, ISOSTEARYL ALCOHOL/CERAMIDE NP, ALOE BARBARDENSIS LEAF EXTRACT COCO NUCIFERA (COCONUT) OIL, SORBIT AN SESQUIOLEATE , VINYL DIMETHICONE CROSSPOLYMER, P O L Y M E T H Y L S I L S E S Q UI O X A N E , SILICA, MICA, ZINC, TIT ANIUM DIOXIDECI77891,IRONOXIDE CI 77491,IRONOXIDE CI77492,IRON OXIDE CI77499,MAGNESIUM SULFATE, PHENOXYETHANOL, CHLORPHENESIN, GLYCERIN, PALMITOYL HEXAPEPTIDE-12, PARFUM
Other InformationProtect the product in this container from excessive hear and direct sun.

* Please review the disclaimer below.

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