NDC 60289-285 Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30

Homosalate, Octisalate, Avobenzone, Ensulizole, And Octocrylene

NDC Product Code 60289-285

NDC Code: 60289-285

Proprietary Name: Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 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: Homosalate, Octisalate, Avobenzone, Ensulizole, 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 60289-285-24

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

NDC Product Information

Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 with NDC 60289-285 is a a human over the counter drug product labeled by Ahava Dead Sea Laboratories Ltd. The generic name of Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 is homosalate, octisalate, avobenzone, ensulizole, 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.

Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 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.

  • HOMOSALATE 3.5 g/50mL
  • OCTISALATE 2.5 g/50mL
  • AVOBENZONE 1.495 g/50mL
  • ENSULIZOLE 1 g/50mL
  • OCTOCRYLENE .43 g/50mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • C15-19 ALKANE (UNII: CI87N1IM01)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • RICE BRAN OIL (UNII: LZO6K1506A)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • CELLULOSE ACETATE (UNII: 3J2P07GVB6)
  • CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • DATE (UNII: H3O7QI5HY7)
  • FOLIC ACID (UNII: 935E97BOY8)
  • PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETETH-20 (UNII: I835H2IHHX)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • PULLULAN (UNII: 8ZQ0AYU1TT)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • GERANIOL (UNII: L837108USY)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • COUMARIN (UNII: A4VZ22K1WT)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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 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: 05-15-2019 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: 12-31-2020 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.

Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 Product Label Images

Extreme Ahava Extreme Daily Firmness And Protection Broad Spectrum Spf30 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

Otc - Purpose

Active ingredientsPurposeAvobenzone [2.99%]sunscreensEnsulizole [2%]sunscreensHomosalate [7%]sunscreensOctisalate [5%]sunscreensOctocrylene [0.86%]sunscreens

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 Center right away

Directions

  • Apply liberally and evenly to clean face 15 minutes before sun exposureapply daily for a clearer, brighter complexionchildren under 6 months of age: 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 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), Glycerin, C15-19 Alkane, Caprylyl Methicone, Cetyl Alcohol, Oryza Sativa (Rice) Bran Oil, Saccharide Isomerate, Cellulose Acetate, Maris Aqua (Dead Sea Water), Dunaliella Salina (Dead Sea Alga) Extract, Cetraria Islandica (Iceland Moss) Extract, Allantoin, Lycium Barbarum (Tibetian GojiBerry) Fruit Extract, Tocopherol (Vitamin E), Phoenix Dactylifera (Date) Fruit Extract, Folic Acid, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Galactoarabinan, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Stearate, Phenoxyethanol, Aminomethyl Propanol, Boron Nitride, Dimethicone, Butylene Glycol, Ceteth-20, Steareth-20, Caprylyl Glycol, PEG-75 Stearate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Hydrogenated Polydecene, Dimethiconol, Sclerotium Gum, Lecithin, Pullulan, Carbomer, Parfum (Fragrance), Geraniol, Citronellol, Coumarin, Alpha Isomethyl Ionone, Limonene, Linalool, Citric Acid, Sodium Citrate, Polysorbate-20, Silica, Potassium Sorbate, Sodium Benzoate.

* Please review the disclaimer below.