NDC 73191-325 Lavelier Divine Day Defense Broad Spectrum Spf 30

Octinoxate, Homosalate, Octisilate, Oxybenzone And Avobenzone

NDC Product Code 73191-325

NDC Code: 73191-325

Proprietary Name: Lavelier Divine Day Defense Broad Spectrum Spf 30 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: Octinoxate, Homosalate, Octisilate, Oxybenzone And Avobenzone 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

  • 73191 - Florida Private Labeling Llc
    • 73191-325 - Lavelier Divine Day Defense Broad Spectrum Spf 30

NDC 73191-325-19

Package Description: 1 JAR in 1 CARTON > 60 g in 1 JAR

NDC Product Information

Lavelier Divine Day Defense Broad Spectrum Spf 30 with NDC 73191-325 is a a human over the counter drug product labeled by Florida Private Labeling Llc. The generic name of Lavelier Divine Day Defense Broad Spectrum Spf 30 is octinoxate, homosalate, octisilate, oxybenzone and avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Florida Private Labeling 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.

Lavelier Divine Day Defense Broad Spectrum Spf 30 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.

  • OCTINOXATE 7.4 g/100g
  • HOMOSALATE 6.2 g/100g
  • OCTISALATE 5.2 g/100g
  • OXYBENZONE 3.1 g/100g
  • AVOBENZONE 1.5 g/100g

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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • MYRISTIC ACID (UNII: 0I3V7S25AW)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Florida Private Labeling Llc
Labeler Code: 73191
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: 08-01-2019 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.

Lavelier Divine Day Defense Broad Spectrum Spf 30 Product Label Images

Lavelier Divine Day Defense Broad Spectrum Spf 30 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

Active Ingredients

Octinoxate    7.40%Homosalate  6.20%Octisalate     5.20%Oxybenzone 3.10%Avobenzone 1.50%

Purpose

Sunscreen

Uses

  • •Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin.Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop Using This Product

And ask doctor if rash or redness develops and lasts.

Keep Out Of Reach Of Children.

If accidental ingestion, call the Poison Control Center right away.

Directions

  • •After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results. •Reapply at least every two (2) hours. •Use water resistant sunscreen if swimming or sweating.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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m. – 2 p.m. •wear long-sleeved shirts, pants, hats and sunglassesFor children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Tocopherol, Retinyl Palmitate, Hydrolyzed Corallina Officinalis, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Sodium PCA, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.

* Please review the disclaimer below.

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