NDC 60289-295 Lumior Exclusive Day Broad Spectrum Spf 20

Avobenzone, Homosalate, And Octisalate

NDC Product Code 60289-295

NDC 60289-295-24

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

NDC Product Information

Lumior Exclusive Day Broad Spectrum Spf 20 with NDC 60289-295 is a a human over the counter drug product labeled by Ahava Dead Sea Laboratories Ltd. The generic name of Lumior Exclusive Day Broad Spectrum Spf 20 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 Exclusive Day Broad Spectrum Spf 20 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.

  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • TREHALOSE (UNII: B8WCK70T7I)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCOL STEARATE (UNII: 0324G66D0E)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • SORBITAN TRISTEARATE (UNII: 6LUM696811)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • LEDIKITE (UNII: D7BC5B0F46)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • COUMARIN (UNII: A4VZ22K1WT)
  • GERANIOL (UNII: L837108USY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CHAMOMILE (UNII: FGL3685T2X)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • FLAX SEED (UNII: 4110YT348C)
  • PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)

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: 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 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: 10-01-2020 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: 12-31-2021 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 Exclusive Day Broad Spectrum Spf 20 Product Label Images

Lumior Exclusive Day Broad Spectrum Spf 20 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

For External Use Only

  • 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, 8698000In US: AHAVA N.A. LLC, New York, NY 10001

Otc - Purpose

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

Inactive Ingredients

AQUA (MINERAL SPRING WATER), BUTYLOCTYL SALICYLATE, POLYESTER-8, CYCLOPENTASILOXANE, OCTYLDODECYL NEOPENTANOATE, PROPANEDIOL (CORN DERIVED), TREHALOSE, GLYCERIN, BUTYLENE GLYCOL, CETEARYL ALCOHOL, STYRENE/ACRYLATES COPOLYMER, GLYCERYL STEARATE, GLYCOL STEARATE, MYRISTYL MYRISTATE, SORBITAN TRISTEARATE, HYDROLYZED CORN PROTEIN, PHENOXYETHANOL, PEG-40 STEARATE, SILICA, DIMETHICONE, CETEARETH-20, SORBITAN LAURATE, XANTHAN GUM, PROPYLENE GLYCOL, BENZOTRIAZOLYL DODECYL P-CRESOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONOL, ILLITE, HYDROXYETHYLCELLULOSE, ACETYL DIPEPTIDE-1 CETYL ESTER, HYDROXYPROPYL CYCLODEXTRIN, PARFUM (FRAGRANCE), BENZYL SALICYLATE, LIMONENE, HEXYL CINNAMAL, LINALOOL, CITRONELLOL, HYDROXYCITRONELLAL, BENZYL BENZOATE, ALPHA ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, COUMARIN, GERANIOL, SODIUM BENZOATE, POTASSIUM SORBATE, MENTHA PIPERITA (PEPPERMINT) LEAF JUICE, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL (VITAMIN E) ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL (VITAMIN E), LINUM USITATISSIMUM (LINSEED) SEED EXTRACT, PALMITOYL TRIPEPTIDE-38, PICHIA FERMENT LYSATE FILTRATE, SEA SILT (DEAD SEA MUD) EXTRACT, MARIS AQUA (DEAD SEA MINERAL ELIXIR).

Uses

  • Helps prevent sunburn

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 each morning to clean face and neck. Embrace your radianceapply 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.