NDC 52773-238 Lorac Foundation Medium Spf20

Octinoxate, Octisalate, Avobenzone

NDC Product Code 52773-238

NDC 52773-238-02

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE (52773-238-01)

NDC Product Information

Lorac Foundation Medium Spf20 with NDC 52773-238 is a a human over the counter drug product labeled by Lorac Cosmetics, Inc.. The generic name of Lorac Foundation Medium Spf20 is octinoxate, octisalate, avobenzone. The product's dosage form is emulsion and is administered via topical form.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Lorac Foundation Medium Spf20 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.


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)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • HEXAMETHYLENE DIISOCYANATE (UNII: 0I70A3I1UF)
  • BENTOQUATAM (UNII: 7F465U79Q1)
  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
  • CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)

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: Lorac Cosmetics, Inc.
Labeler Code: 52773
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: 10-01-2013 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: 12-31-2022 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".

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Lorac Foundation Medium Spf20 Product Label Images

Lorac Foundation Medium Spf20 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

Avobenzone 3.0%Octinoxate 7.5%Ocitsalate 5.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (See Directions), decreases the rist of skin cancer and early skin-aging cause by the sun.

Warnings

  • For exteral use OnlyKeep away  from the eye areaStop use if irritation occursIf irritation persists consult a health practitioner

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Do Not Use

Do not use on damaged or broken skin

Directions

  • Apply 15 minutes prior to sun exposure and reapply as neededSpending time in the sun increases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with Broad Spectrum value at 15 or higher and other sun protection measures includingLimit time in the sun, expecially from 10 a.m. to 2 p.m.Wear long-sleeved shirts, hats, pants and sunglassesChildren under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, POLYMETHYLSILSESUIOXANE, ETHYLHEXYL PALMITATE, GLYCERIN, NEOPENTYL GLYCOL DIHEPTANOATE, TRIMETHYLSILOXYSILICATE,  HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, QUATERNIUM-90 BENTONITE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, POTASSIUM SORBATE, PHENYL TRIMETHICONE, TOCOPHERYL ACETATE, POLYGLYCERYL-3 BEESWAX,  MICROCRYSTALINE WAX, PROPYLENE CARBONATE, RETINYL PALMITATE, POLYHYDROXYSTEARIC ACID, LECITHIN, ISOPROPYL MYRISTATE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, PHENOXYETHANOL, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, MAY CONTAIN : TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI77492, CI 77491, CI 77499), MICA (CI 77019).

* Please review the disclaimer below.