NDC 79625-001 Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer

Homosalate, Octisalate, And Zinc Oxide

NDC Product Code 79625-001

NDC CODE: 79625-001

Proprietary Name: Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer 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, And Zinc Oxide 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

  • 79625 - Ascendant Beauty Llc

NDC 79625-001-07

Package Description: 15 mL in 1 JAR

NDC 79625-001-19

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

NDC Product Information

Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer with NDC 79625-001 is a a human over the counter drug product labeled by Ascendant Beauty Llc. The generic name of Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer is homosalate, octisalate, and zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ascendant Beauty Llc

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.

Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer 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 150 mg/mL
  • OCTISALATE 50 mg/mL
  • ZINC OXIDE 30 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
  • WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
  • HIMANTHALIA ELONGATA (UNII: 21RND18XRR)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • MASTOCARPUS STELLATUS (UNII: 6T087FC66H)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • HONEY (UNII: Y9H1V576FH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ETHYL FERULATE (UNII: 5B8915UELW)
  • TREHALOSE (UNII: B8WCK70T7I)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ISOPENTYLDIOL (UNII: 19NOL5474Q)
  • PALMITOYL TETRAPEPTIDE-10 (UNII: 6Q6H1PKC05)
  • FARNESOL (UNII: EB41QIU6JL)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 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: Ascendant Beauty Llc
Labeler Code: 79625
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: 04-01-2021 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 - 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.

Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer Product Label Images

Jlo Beauty That Big Screen Broad Spectrum Spf 30 Moisturizer 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 Fact Label

For external use only. Do not use on damaged or broken skin.

Dist.by/par. Ascendant Beauty, LLC., El Segundo, CA 90245.

Active Ingredient

Homosalate - 15.0%Octisalate – 5.0%Zinc – 3.0%

Purpose

Sunscreen

Use

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 ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply a generous amount. Use daily in the morning. At least 15 minutes before sun exposureReapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingChildren under 6 months of age: ask a doctorSun protection measures, Spending time in the sun increases your risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun, especially from 10 a.am. to 2 p.m.Wear long0sleeved shirts, pants, hats and sunglasses.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Homosalate – 15.0%, Octisalate - 5.0%, Zinc Oxide - 3.0%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydrolyzed Vegetable Protein, Nelumbo Nucifera Flower Extract, Withania Somnifera Root Extract, Himanthalia Elongata Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Gigartina Stellata Extract, Hydrogenated Lecithin, Chondrus Crispus Extract, Camellia Sinensis Leaf Extract, Aspalathus Linearis Extract, Boswellia Serrata Extract, Honey Extract, Tocopheryl Acetate, Tocopherol, Ethyl Ferulate Trehalose, Disodium EDTA, Cetyl Palmitate, Bisabolol, Triethoxycaprylylsilane, Sorbitan Stearate, Polysorbate 80, Butylene Glycol, Sodium Hyaluronate, Isopentyldiol, Palmitoyl Tetrapeptide-10, Farnesol, Tetrapeptide-14, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, Citric Acid, Phenoxyethanol, Sodium Benzoate.

* Please review the disclaimer below.