NDC 57627-156 Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman
Octinoxate, Titanium Dioxide Liquid Topical

Product Information

Product Code57627-156
Proprietary Name 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.
Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman
Non-Proprietary Name 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.
Octinoxate, Titanium Dioxide
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Merle Norman Cosmetics, Inc.
Labeler Code57627
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-12-2012
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 57627-156-02

Package Description: 1 TUBE in 1 CARTON > 35 g in 1 TUBE (57627-156-01)

Product Details

Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman is a human over the counter drug product labeled by Merle Norman Cosmetics, Inc.. The generic name of Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman is octinoxate, titanium dioxide. The product's dosage form is liquid and is administered via topical form.


What are Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • MICA (UNII: V8A1AW0880)
  • TALC (UNII: 7SEV7J4R1U)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
  • GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
  • CERAMIDE 3 (UNII: 4370DF050B)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • SOYBEAN GERM (UNII: JBW2VHD14M)
  • ECHINACEA PURPUREA (UNII: QI7G114Y98)
  • FENNEL SEED (UNII: G3QC02NIE6)
  • EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CUCUMBER (UNII: YY7C30VXJT)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ISOCETYL ALCOHOL (UNII: 1800H64066)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LAURETH-7 (UNII: Z95S6G8201)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)


* Please review the disclaimer below.

Sheer Defense Tinted Moisturizer Spf 15 Ml 40 Merle Norman Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active Ingredients Purpose

Octinoxate 7.5% Sunscreen

Titanium Dioxide 4.37% Sunscreen


Otc - Purpose



Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



stop use and ask a doctor if rash occurs.


Warnings



Warnings

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.


Dosage & Administration



Directions

For Sunscreen use:

apply liberally and evenly 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

Sun Protection Measures.

Spending time 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:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats and sunglasses

Childdren under 6 months: Ask a doctor


Inactive Ingredient



Inactive ingredients:

Water (Aqua), Dimethicone, Butylene Glycol, Glyceryl Stearate SE, Mica, Talc, Iron Oxides, Glyceryl Dilaurate, Glyceryl Behenate, Ceramide 3, Saccharide Isomerate, Allantoin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Glycine Soja (Soybean) Germ Extract, Echinacea Purpurea Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Equisetum Arvense Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Oleifera Leaf Extract, Lecithin, Petrolatum, Palmitic Acid, Polyglyceryl-10 Decaoleate, Polyacrylamide, PEG-12 Dimethicone, octyldodecyl Stearoyl Stearate, Steareth-20, C13-14 Isoparaffin, Isocetyl Alcohol, Propylene Glycol, Laureth-7, Silica, Cyclodextrin, Disodium EDTA, Phenoxyethanol, Tetrasodium EDTA, BHT, Diazolidinyl Urea, Fragrance (Parfum)


Package Label.Principal Display Panel



Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15

ML40

Merle Norman

Established in Los Angeles since 1931

35g Net Wt. 1.25 Oz


* Please review the disclaimer below.