NDC 44099-001 Skin Md Natural

Octinoxate, Octisalate, Homosalate

NDC Product Code 44099-001

NDC 44099-001-01

Package Description: 117 mL in 1 BOTTLE

NDC 44099-001-02

Package Description: 236 mL in 1 BOTTLE

NDC 44099-001-03

Package Description: 3785 mL in 1 BOTTLE

NDC 44099-001-04

Package Description: 100 mL in 1 TUBE

NDC 44099-001-05

Package Description: 200 mL in 1 TUBE

NDC Product Information

Skin Md Natural with NDC 44099-001 is a a human over the counter drug product labeled by 21st Century Formulations. The generic name of Skin Md Natural is octinoxate, octisalate, homosalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: 21st Century Formulations

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.

Skin Md Natural 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.

  • OCTINOXATE 7 mg/100mL
  • OCTISALATE 5 mg/100mL
  • HOMOSALATE 3 mg/100mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • COMFREY LEAF (UNII: DG4F8T839X)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
  • CHONDRUS CRISPUS (UNII: OQS23HUA1X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)

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.
  • 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: 21st Century Formulations
Labeler Code: 44099
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: 08-19-2008 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.

Skin Md Natural Product Label Images

Skin Md Natural 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

Octinoxate 7%Octisalate 5%Homosalate 3%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.Decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do Not Use

On damaged or broken skin

Stop Use And Ask A Doctor

If rash occurs.

When Using This Product

Keep out of eyes. Rinse with water to remove.

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.Reapply at least every 2 hours.Spending time in the sun increases your risk of skin cancer and early skin aging.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

Questions?

Call toll free 1-800-540-4790®2013 Made in USA21st Century FormulationsBeverly Hills, CA 90210www.skinmdnatural.com

* Please review the disclaimer below.