NDC 54151-101 Ingenue

  1. Labeler Index
  2. Ingenue, Llc
  3. NDC: 54151-101 Ingenue

NDC Product Code 54151-101

NDC CODE: 54151-101

Proprietary Name: Ingenue 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as purpose:sunscreen

NDC Code Structure

NDC 54151-101-26

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE

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

NDC Product Information

Ingenue with NDC 54151-101 is product labeled by Ingenue, Llc. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • WATERMELON (UNII: 231473QB6R)
  • STEARETH-21 (UNII: 53J3F32P58)
  • SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CHAMOMILE (UNII: FGL3685T2X)
  • CUCUMBER (UNII: YY7C30VXJT)
  • CARROT (UNII: L56Z1JK48B)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
  • MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
  • PEA (UNII: W4X7H8GYFM)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ANNATTO (UNII: 6PQP1V1B6O)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FERULIC ACID (UNII: AVM951ZWST)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
  • SORBIC ACID (UNII: X045WJ989B)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Product Labeler Information

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

Labeler Name: Ingenue, Llc
Labeler Code: 54151
Start Marketing Date: 06-15-2012 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.

Ingenue Product Label Images

Ingenue 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

Otc - Active Ingredient

Active Ingredient:Zinc Oxide 14.5%

Otc - Purpose

Purpose:Sunscreen

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.

Indications & Usage

Uses:Helps prevent sunburn

Warnings

  • Warnings:For external use onlyDo 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.

Dosage & Administration

Directions:Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: ask a doctorSun 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.

Inactive Ingredient

Inactive Ingredients:Alcohol, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate,
Glycerin, C13-14 Isoparaffin, Cyclomethicone, Glyceryl Stearate, Laureth-7, PEG-100
Stearate, Polyacrylamide, Citrullus Lanatus (Watermelon) Fruit Extract, Steareth-21,
Synthetic Beeswax, Dimethicone, Olea Europaea (Olive) Fruit Oil, Helianthus
Annuus (Sunflower) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla
Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract,
Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Lentinus
Edodes (Shiitake Mushroom) Extract, Macrocystis Pyrifera (Kelp) Extract, Pisum
Sativum (Pea) Extract, Caprylyl Glycol, Castor Oil Phosphate, Sodium Benzoate, Potassium
Sorbate, Annatto, Dipotassium Glycyrrhizinate, Disodium EDTA, Ferulic Acid, Maltodextrin,
Phyllanthus Emblica Fruit Extract, Sodium Hyaluronate, Tetrahydro Curcuminoids,
Sorbic Acid, Tetrahexyldecyl Ascorbate, Phospholipids, Retinyl Palmitate, Tocopheryl
Acetate, Ascorbyl Palmitate, Tocopherol, Sodium Dehydroacetate, Phenoxyethanol,
water.

* Please review the disclaimer below.