NDC 70605-006 Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15

Avobenzone, Octinoxate, Octisalate, And Oxybenzone

NDC Product Code 70605-006

NDC CODE: 70605-006

Proprietary Name: Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 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: Avobenzone, Octinoxate, Octisalate, And Oxybenzone 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

NDC 70605-006-41

Package Description: 120 mL in 1 TUBE

NDC 70605-006-57

Package Description: 50 mL in 1 TUBE

NDC 70605-006-89

Package Description: 20 mL in 1 TUBE

NDC Product Information

Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 with NDC 70605-006 is a a human over the counter drug product labeled by Guthy-renker Llc. The generic name of Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 is avobenzone, octinoxate, octisalate, and oxybenzone. The product's dosage form is cream and is administered via topical form.

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.

Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 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)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MUSKMELON (UNII: ZV095H5633)
  • ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • TETRAPEPTIDE-21 (UNII: 179JUC43HU)
  • BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ALCOHOL (UNII: 3K9958V90M)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Guthy-renker Llc
Labeler Code: 70605
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: 04-30-2016 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 - 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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Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 Product Label Images

Meaningful Beauty Cindy Crawford Skin Brightening Decollete And Neck Treatment Spf 15 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

Other

Drug Fact Label

Distributed by: Meaningful Beauty®100 N. Sepulveda Blvd., El Segundo, CA 90245

Active Ingredient

Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 5.0%

Purpose

Sunscreen

Uses

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

Warnings

For external use only.

Otc - Do Not Use

Do not use on damage or broken skin.

Otc - When Using

When using this product this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of 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 exposure.Use a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hrs.children under 6 months, ask a doctor.Sun Protection Measures. Spending time in the sun increases your risk of skin cancer early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Cetearyl Alcohol, Butylene Glycol, Glycerin, PEG-40 Stearate, PEG-100 Stearate, Glyceryl Stearate, Dimethicone, Cucumis Melo (Melon) Fruit Extract, Arctostaphylos Uva Ursi Leaf Extract, Ascorbyl Methylsilanol Pectinate, Magnesium Ascorbyl Phosphate, Tetrapeptide-21, Biosaccharide Gum-1, Dipotassium Glycyrrhizate, Caprylyl Glycol, Hydrogenated Vegetable Oil, Alcohol, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Cholesterol, Ethylhexylglycerin, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Steareth-20, Disodium EDTA, Potassium Sorbate, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol, Fragrance.

* Please review the disclaimer below.