NDC 60289-298 Lumior Empowered Day Moisturizer Broad Spectrum Spf 15

Avobenzone, Homosalate, And Octisalate

NDC Product Code 60289-298

NDC CODE: 60289-298

Proprietary Name: Lumior Empowered Day Moisturizer Broad Spectrum 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, Homosalate, And Octisalate 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

  • 60289 - Ahava Dead Sea Laboratories Ltd
    • 60289-298 - Lumior Empowered Day Moisturizer Broad Spectrum Spf 15

NDC 60289-298-24

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

NDC Product Information

Lumior Empowered Day Moisturizer Broad Spectrum Spf 15 with NDC 60289-298 is a a human over the counter drug product labeled by Ahava Dead Sea Laboratories Ltd. The generic name of Lumior Empowered Day Moisturizer Broad Spectrum Spf 15 is avobenzone, homosalate, and octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ahava Dead Sea Laboratories Ltd

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.

Lumior Empowered Day Moisturizer Broad Spectrum 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.

  • AVOBENZONE 30 mg/mL
  • HOMOSALATE 70 mg/mL
  • OCTISALATE 50 mg/mL

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)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • TREHALOSE (UNII: B8WCK70T7I)
  • HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • SORBITAN TRISTEARATE (UNII: 6LUM696811)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • CHAMOMILE (UNII: FGL3685T2X)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)

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: Ahava Dead Sea Laboratories Ltd
Labeler Code: 60289
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-01-2021 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 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.

Lumior Empowered Day Moisturizer Broad Spectrum Spf 15 Product Label Images

Lumior Empowered Day Moisturizer Broad Spectrum 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 Facts

  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10a.m.-2 p.m.wear long-sleeved shirts, pants, hats and sunglasses

Manufactured by AHAVA Dead Sea Laboratories, Dead Sea, Israel, 8698000

Otc - Purpose

Active ingredientsPurposeAvobenzone [3%]sunscreensHomosalate [7%]sunscreensOctisalate [5%]sunscreens

Inactive Ingredients

Aqua (Mineral Spring Water), Butyloctyl Salicylate, Polyester-8, Octyldodecyl Neopentanoate, Trehalose, HDI/Trimethylol Hexyl-lactone Crosspolymer, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Biosaccharide Gum-4, Glyceryl Stearate, Caprylyl Glycol, Methylpropanediol, Isodecyl Isononanoate, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Glycol Stearate, Myristyl Myristate, Sorbitan Tristearate, Propanediol (Corn derived), Dimethicone, Dimethiconol, Benzotriazolyl Dodecyl p-Cresol, Propylene Glycol, Silica, 1,2-Hexanediol, Lactic Acid, Ceteareth-20, Peg-40 Stearate, Parfum (Fragrance), Allantoin, Xanthan Gum, Tocopheryl (Vitamin E) Acetate, Tocopherol (Vitamin E), Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Chamomilla Recutita (Matricaria) Flower Extract, Maris Aqua (Dead Sea Mineral Elixir).

Uses

  • Helps prevent sunburn

Warnings

For External Use Only

Otc - When Using

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

Otc - Stop Use

Stop use and consult a doctor if rash or irritation develops and lasts

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Centre right away

Directions

  • Apply every morning to a clean face and neck for recharged, protected skinapply daily for a clearer, brighter complexionchildren under 6 months of age: Ask a doctor

Other Information

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

* Please review the disclaimer below.