NDC 43419-768 Laneige Hydro Uv Defense

Avobenzone, Homosalate, Octisalate, And Octocrylene Lotion

NDC Product Code 43419-768

NDC CODE: 43419-768

Proprietary Name: Laneige Hydro Uv Defense 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, Homosalate, Octisalate, And Octocrylene Lotion 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

  • 43419 - Amorepacific Corporation

NDC 43419-768-08

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

NDC Product Information

Laneige Hydro Uv Defense with NDC 43419-768 is a a human over the counter drug product labeled by Amorepacific Corporation. The generic name of Laneige Hydro Uv Defense is avobenzone, homosalate, octisalate, and octocrylene lotion. The product's dosage form is lotion and is administered via topical form.

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.

Laneige Hydro Uv Defense 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.

  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • GERANIOL (UNII: L837108USY)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ABELMOSCHUS MOSCHATUS SEED (UNII: UN2QZ55I88)
  • POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)
  • C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MANGANESE SULFATE (UNII: W00LYS4T26)
  • ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • C14-22 ALCOHOLS (UNII: B1K89384RJ)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • CENTELLA ASIATICA FLOWERING TOP (UNII: J02K2IV2PB)
  • BROCCOLI SPROUT (UNII: 128UH9LOAE)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • TRISILOXANE (UNII: 9G1ZW13R0G)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: Amorepacific Corporation
Labeler Code: 43419
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: 12-31-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Laneige Hydro Uv Defense Product Label Images

Laneige Hydro Uv Defense 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 Facts

Inactive Ingredients

WATER / AQUA / EAU, PROPANEDIOL, BUTYLOCTYL SALICYLATE, GLYCERIN, DIMETHICONE, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, TRISILOXANE, VP/EICOSENE COPOLYMER, CYCLOPENTASILOXANE, TRIMETHYLSILOXYSILICATE, C14-22 ALCOHOLS, 1,2-HEXANEDIOL, GLYCERYLSTEARATE, PEG-100 STEARATE, PHENYL TRIMETHICONE, CETYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, CAPRYLYL METHICONE, POLYACRYLATE-13, FRAGRANCE / PARFUM, POLYISOBUTENE, C12-20 ALKYL GLUCOSIDE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYSORBATE 20, SORBITAN ISOSTEARATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, BUTYLPHENYL METHYLPROPIONAL, HYDROXYCITRONELLAL, LIMONENE, BENZYL SALICYLATE, ALPHA-ISOMETHYL IONONE, GERANIOL, CITRONELLOL, BUTYLENE GLYCOL, GLUCOSE, ALOE BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, CENTELLA ASIATICA FLOWER/LEAF/STEM EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, HIBISCUS ABELMOSCHUS EXTRACT, MAGNESIUM SULFATE, CALCIUM CHLORIDE, TOCOPHEROL, XANTHAN GUM, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, MANGANESE SULFATE, CHENOPODIUM QUINOA SEED EXTRACT, ZINC SULFATE, ASCORBYL GLUCOSIDE

WATER / AQUA / EAU, DIMETHICONE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PROPYLHEPTYL CAPRYLATE, CETYL PEG/PPG-10/1 DIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPANEDIOL, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SYNTHETIC FLUORPHLOGOPITE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, 1,2-HEXANEDIOL, MAGNESIUM SULFATE, POLYHYDROXYSTEARIC ACID, METHYL METHACRYLATE CROSSPOLYMER, ALUMINA, FRAGRANCE / PARFUM, STEARIC ACID, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, SOLIDAGO VIRGAUREA (GOLDENROD) EXTRACT, EUGENIA CARYOPHYLLUS (CLOVE) BUD EXTRACT, ETHYLHEXYLGLYCERIN, DICAPRYLYL CARBONATE, MICA, SILICA, TOCOPHEROL, IRON OXIDES (CI 77491), TRIETHOXYCAPRYLYLSILANE

Active Ingredients

Avobenzone 2.5%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf 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 - When Using

  • When using 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureReapply at least every 2 hours.Use a water-resistant sunscreen if swimming or sweating.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.Children under 6 months of age : Ask a doctor.

Other Information

  • Protect the product in this container from excessive heat and direct sun

Questions?

[email protected]

* Please review the disclaimer below.