NDC 60289-296 Lumior Men Facial Moisturizer Broad Spectrum Spf 15

Avobenzone, Octisalate, And Octocrylene

NDC Product Code 60289-296

NDC CODE: 60289-296

Proprietary Name: Lumior Men Facial 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, Octisalate, And Octocrylene 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

NDC 60289-296-24

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 50 mL in 1 BOTTLE, GLASS

NDC Product Information

Lumior Men Facial Moisturizer Broad Spectrum Spf 15 with NDC 60289-296 is a a human over the counter drug product labeled by Ahava Dead Sea Laboratories Ltd. The generic name of Lumior Men Facial Moisturizer Broad Spectrum Spf 15 is avobenzone, octisalate, and octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Ahava Dead Sea Laboratories Ltd

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.

Lumior Men Facial 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
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 27.4 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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-40 STEARATE (UNII: ECU18C66Q7)
  • SORBITAN TRISTEARATE (UNII: 6LUM696811)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
  • ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • UREA (UNII: 8W8T17847W)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • INVERT SUGAR (UNII: ED959S6ACY)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • .BETA.-SITOSTEROL (UNII: S347WMO6M4)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • FARNESOL (UNII: EB41QIU6JL)
  • COUMARIN (UNII: A4VZ22K1WT)
  • EUGENOL (UNII: 3T8H1794QW)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CREATINE (UNII: MU72812GK0)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALANINE (UNII: OF5P57N2ZX)
  • GLYCINE (UNII: TE7660XO1C)
  • MAGNESIUM ASPARTATE (UNII: R17X820ROL)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • ALLANTOIN (UNII: 344S277G0Z)
  • HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CUCUMBER (UNII: YY7C30VXJT)
  • GINGER (UNII: C5529G5JPQ)
  • MYRRH (UNII: JC71GJ1F3L)
  • CHINESE CINNAMON (UNII: WS4CQ062KM)
  • GINKGO (UNII: 19FUJ2C58T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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 Men Facial Moisturizer Broad Spectrum Spf 15 Product Label Images

Lumior Men Facial 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

Manufactured by AHAVA Dead Sea Laboratories, Dead Sea, Israel, 8698000In US: AHAVA N.A. LLC, New York, NY 10001

Otc - Purpose

Active ingredientsPurposeAvobenzone [3%]sunscreenOctisalate [5%]sunscreenOctocrylene [2.74%]sunscreen

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 Contol Center right away

Directions

  • Apply every morning to a clean face. Fortify your skin!use a water-resistant sunscreen if swimming or sweating.reapply at least every 2 hours.children under 6 months of age: Ask a doctor

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

Inactive Ingredients

AQUA (MINERAL SPRING WATER), BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, GLYCERIN, PEG-40 STEARATE, SORBITAN TRISTEARATE, DIMETHICONE, NYLON 6/12, OCTYLDODECYL NEOPENTANOATE, CETEARYL OLIVATE, SORBITAN OLIVATE, CYCLOMETHICONE, PHENOXYETHANOL, CETYL PALMITATE, CETYL PHOSPHATE, SORBITAN PALMITATE, DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES, ISOSTEARYL ISOSTEARATE, BISABOLOL, UREA, POTASSIUM SORBATE, SODIUM BENZOATE, BENZOIC ACID, QUATERNIUM-18 HECTORITE, PROPANEDIOL, SACCHARIDE HYDROLYSATE, PVP, ETHYLHEXYLGLYCERIN, LACTIC ACID, XANTHAN GUM, PROPYLENE CARBONATE, BETA-SITOSTEROL, HYDROGENATED VEGETABLE GLYCERIDES CITRATE, PARFUM (FRAGRANCE), LINALOOL, LIMONENE, ALPHA ISOMETHYL IONONE, FARNESOL, COUMARIN, EUGENOL, BENZYL SALICYLATE, SALICYLIC ACID, 1,2-HEXANEDIOL, ASCORBYL PALMITATE, CREATINE, CAPRYLYL GLYCOL, DEHYDROACETIC ACID, SODIUM HYDROXIDE, LECITHIN, PROPYLENE GLYCOL, PSEUDOALTEROMONAS FERMENT EXTRACT, ALANINE, GLYCINE, MAGNESIUM ASPARTATE, TOCOPHEROL (VITAMIN E), PANTHENOL (PRO VITAMIN B5), OPUNTIA FICUS-INDICA FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, ALLANTOIN, PORPHYRA UMBILICALIS (ALGA) EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, COMMIPHORA ABYSSINICA (MYRRH) RESIN EXTRACT, SANGUISORBA OFFICINALIS (GREAT BURNET) ROOT EXTRACT, CINNAMOMUM CASSIA (CHINESE CINNAMON) BARK EXTRACT, SQUALENE (PLANT SQUALENE), GINKGO BILOBA LEAF EXTRACT, ALOE BARBADENSIS (ALOE-VERA) LEAF JUICE, SODIUM (HYALURONIC ACID SALT) HYALURONATE, MARIS AQUA (DEAD SEA MINERAL ELIXIR).

Other Information

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