NDC 54111-153 Naturopathica Calendula And Butterfly Ginger Spf 40

Zinc Oxide

NDC Product Code 54111-153

NDC 54111-153-50

Package Description: 1 JAR in 1 CARTON > 15 mL in 1 JAR

NDC Product Information

Naturopathica Calendula And Butterfly Ginger Spf 40 with NDC 54111-153 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Naturopathica Calendula And Butterfly Ginger Spf 40 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bentley Laboratories, 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.

Naturopathica Calendula And Butterfly Ginger Spf 40 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.

  • ZINC OXIDE 19.92375 g/100mL

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)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GRIFFONIA SIMPLICIFOLIA SEED (UNII: LUS5142TMY)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROXYLITOL (UNII: 8XWR7NN42F)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • TREHALOSE (UNII: B8WCK70T7I)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
  • CAFFEINE (UNII: 3G6A5W338E)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • LUTEIN (UNII: X72A60C9MT)

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: Bentley Laboratories, Llc
Labeler Code: 54111
FDA Application Number: part347 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: 01-31-2021 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 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’.

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Naturopathica Calendula And Butterfly Ginger Spf 40 Product Label Images

Naturopathica Calendula And Butterfly Ginger Spf 40 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

Drug Facts

Active Ingredient Zinc Oxide 19.92375%

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed withother sun protection measures (see directions),decreases the risk of skin cancer and early skinaging caused by the sun

Warnings

For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes.Rinse with water to remove.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 liberally 15 minutes before sun exposure• reapply at least every two hours• use a 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 15 or higher and other   sun protection measures including:• limit time in the sun, especially from 10a.m. - 2p.m.• wear long-sleeved shirts, pants, hats and sunglasses• children under 6 months of age: consult a doctor

Other Information

Protect the product in this container from excessive heat and direct sun

Otc - Questions

Questions or Comments? call toll free 646-979-3997

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Coco-Caprylate/Caprate,Glycerin, Galactoarabinan, Butyloctyl Salicylate, Griffonia Simplicifolia SeedExtract, Cetearyl Alcohol, Propanediol, Caprylic/Capric Triglyceride, UndariaPinnatifida Extract, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin,Palmitic Acid, 1,2-Hexanediol, Borago Officinalis Seed Oil, Caprylyl Glycol,Hydrolyzed Vegetable Protein, Xylitylglucoside, Isostearic Acid, CetearylGlucoside, Xanthan Gum, Anhydroxylitol, Citric Acid, Trehalose, CamelliaSinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum FlowerExtract, Xylitol, Polyhydroxystearic Acid, Lecithin, Hedychium CoronariumRoot Extract, Lactobacillus Ferment, Leuconostoc/Radish Root FermentFiltrate, Polygonum Aviculare Extract, Caffeine, Potassium Sorbate, SodiumBenzoate, Carthamus Tinctorius (Safflower) Seed Oil, Calendula OfficinalisFlower Extract, Xanthophylls

Product Label

NATUROPATHICA®FOR DEEPER BEAUTYCALENDULA &BUTTERFLY GINGEREYE CREAMBROAD SPECTRUM SPF 40 SUNSCREENFLUIDE ESSENTIALHYDRATANT0.5 FL OZ/50 MLDistributed by: Naturopathica Holistic Health, Inc.New York, NY 10001. Dublin, IrelandNaturopathica.com 646-979-3997res

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