NDC 76119-5309 Mally Lip Defender

NDC Product Code 76119-5309

NDC CODE: 76119-5309

Proprietary Name: Mally Lip Defender 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.

NDC Code Structure

  • 76119 - Mallygirl, Llc

NDC 76119-5309-1

Package Description: 1 TUBE, WITH APPLICATOR in 1 BOX > 3.5 g in 1 TUBE, WITH APPLICATOR

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Mally Lip Defender with NDC 76119-5309 is a product labeled by Mallygirl, Llc. The product's dosage form is and is administered via form.

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.

  • POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • OCTYLDECANOL (UNII: 07UG7TSU58)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MICA (UNII: V8A1AW0880)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • D&C RED NO. 6 (UNII: 481744AI4O)
  • D&C RED NO. 7 (UNII: ECW0LZ41X8)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mallygirl, Llc
Labeler Code: 76119
Start Marketing Date: 05-01-2012 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Mally Lip Defender 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 2.0%Octinoxate 7.0%

Purpose

SunscreenSunscreen

Use

  • 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.

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swollowed, 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 hours.Children under 6 months: ask a doctor.Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including:Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.Wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2  triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba),  Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.