NDC 43596-0890 Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel

Octinoxate, Zinc Oxide

NDC Product Code 43596-0890

NDC CODE: 43596-0890

Proprietary Name: Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel 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, 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

  • 43596 - Ventura Corporation Ltd
    • 43596-0890 - Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel

NDC 43596-0890-1

Package Description: 4 g in 1 CARTON

NDC Product Information

Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel with NDC 43596-0890 is a a human over the counter drug product labeled by Ventura Corporation Ltd. The generic name of Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel is octinoxate, zinc oxide. The product's dosage form is stick and is administered via topical form.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel 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.


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.

  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • TRIDECYL STEARATE (UNII: A8OE252M6L)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TALC (UNII: 7SEV7J4R1U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • BRAZILIAN PEPPER (UNII: SUG822G7CD)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
  • MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
  • DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
  • TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
  • POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CERAMIDE NP (UNII: 4370DF050B)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • CERESIN (UNII: Q1LS2UJO3A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)

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: Ventura Corporation Ltd
Labeler Code: 43596
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: 06-16-2021 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.

Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel Product Label Images

Ultra Balm Moisturizing Protective Balm For Lips Spf 20 Nude Caramel 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

Otc - Active Ingredient

Active Ingredients PurposeOctinoxate 7.50% SunscreenZinc Oxide 4.90% Sunscreen

Otc - Purpose

  • UsesHelps prevent sunburn.

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

  • DirectionsApply liberally and evenly 15 minutes before sun exposure.Reapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweating.Children under 6 months of age: Ask a doctor

Inactive Ingredient

Inactive ingredients: octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, silica, jojoba esters, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, tocopheryl acetate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, schinus terebinthifolia seed extract, phenoxyethanol, tridecyl stearate, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, neopentyl glycol dicaprylate/dicaprate, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np, lecithin.
may contain:
mica, titanium dioxide, synthetic fluorphlogopite, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, talc.

Other Safety Information

  • Other informationProtect the product in this container from excessive heat and direct sun

Ultra Balm Spf 20 Nude Caramel

L'BELULTRA BALMMoisturizing protective balm for lips SPF 20 Nude CaramelNet. Wt. 0.14 oz (4 g)

* Please review the disclaimer below.