NDC 49967-162 Garnier Ombrelle Spf 30 Face Ultra Light

Octocrylene, Drometrizole Trisiloxane, Avobenzone, Titanium Dioxide And Terephthalylidene Dicamphor Sulfonic Acid

NDC Product Code 49967-162

NDC CODE: 49967-162

Proprietary Name: Garnier Ombrelle Spf 30 Face Ultra Light 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: Octocrylene, Drometrizole Trisiloxane, Avobenzone, Titanium Dioxide And Terephthalylidene Dicamphor Sulfonic Acid 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

  • 49967 - L'oreal Usa Products Inc
    • 49967-162 - Garnier Ombrelle Spf 30 Face Ultra Light

NDC 49967-162-01

Package Description: 75 mL in 1 TUBE

NDC Product Information

Garnier Ombrelle Spf 30 Face Ultra Light with NDC 49967-162 is a a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of Garnier Ombrelle Spf 30 Face Ultra Light is octocrylene, drometrizole trisiloxane, avobenzone, titanium dioxide and terephthalylidene dicamphor sulfonic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: L'oreal Usa Products Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the 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.

Garnier Ombrelle Spf 30 Face Ultra Light 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 50 mg/mL
  • DROMETRIZOLE TRISILOXANE 40 mg/mL
  • AVOBENZONE 30 mg/mL
  • TITANIUM DIOXIDE 29 mg/mL
  • ECAMSULE 10 mg/mL

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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: L'oreal Usa Products Inc
Labeler Code: 49967
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: 10-10-2011 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 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.

Garnier Ombrelle Spf 30 Face Ultra Light Product Label Images

Garnier Ombrelle Spf 30 Face Ultra Light 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

Octocrylene 5%Drometrizole Trisiloxane 4%Avobenzone 3%Titanium Dioxide 2.9%Terephthalylidene Dicamphor Sulfonic Acid 1%

Caution

For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

Directions

Apply generously 15 to 30 minutes before sun exposure. Reapply at least every 2 hours or after swimming, washing, towel drying or perspiring heavily.

Others

Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Pentylene Glycol, Stearic Acid, Triethanolamine, Potassium Cetyl Phosphate, Propylene Glycol, Panthenol, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Cetyl Alcohol, Dimethicone, Methylparaben, Aluminum Hydroxide, Capryly Glycol, Ethylparaben, Carbomer, Tocopherol, Xanthan Gum, Disodium EDTA

* Please review the disclaimer below.