NDC 73022-003 Natural Sunscreen For Kids/baby Spf 40

Zinc Oxide

NDC Product Code 73022-003

NDC Code: 73022-003

Proprietary Name: Natural Sunscreen For Kids/baby Spf 40 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: 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

  • 73022 - Hush Brands Inc.
    • 73022-003 - Natural Sunscreen For Kids/baby

NDC 73022-003-01

Package Description: 100 g in 1 TUBE

NDC Product Information

Natural Sunscreen For Kids/baby Spf 40 with NDC 73022-003 is a a human over the counter drug product labeled by Hush Brands Inc.. The generic name of Natural Sunscreen For Kids/baby Spf 40 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Hush Brands Inc.

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.

Natural Sunscreen For Kids/baby 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 20.5 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DILAURYL CITRATE (UNII: 5OYS3G306B)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GINKGO (UNII: 19FUJ2C58T)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
  • LONICERA CONFUSA FLOWER (UNII: 3JV904IJ0V)
  • METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)
  • OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
  • JOJOBA OIL (UNII: 724GKU717M)
  • SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Hush Brands Inc.
Labeler Code: 73022
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: 04-15-2019 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.

Natural Sunscreen For Kids/baby Spf 40 Product Label Images

Natural Sunscreen For Kids/baby 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

Active Ingredients (W/W )/ Ingrédients Actifs (P/P)

Zinc Oxide 20.5%

Purpose/ Utilité

Sunscreen/ Écran solaire

Use/ Usage

Helps prevent sunburn/ Aide à prévenir les coups de soleil

Warnings / Mises En Garde

For external use only/ Pour usage externe seulement

Otc - Do Not Use

Do not use on damaged or broken skin/ Ne pas utiliser sur la peau endommagée ou présentant des lesions

Otc - Stop Use

Stop use and ask a doctor if rash occurs/ Cesser d’utiliser ce produit et consultez un médecin si une éruption cutanée apparait

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove/ Lorsque vous utilisez ce produit éviter tout contact avec les yeux. Rincer à l’eau le cas échéant.

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.Store at room temperature 15-30°C (59-86°F)/ Garder hors de la portée des enfants. Topique. En cas d’ingestion, consulter un médecin immédiatement ou appeler un centre antipoison. Conserver à la température de la pièce entre 15-30°C (59-86°F)

Directions / Mode D’Emploi

  • Apply liberally and generously 15 minutes before sun exposure. • reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours. 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 am - 2 pm • wear long-sleeved shirts, pants, hats, and sunglasses. • For use on children less than 6 months of age, consult a doctorAppliquer abondamment et généreusement 15 minutes avant l’exposition au soleil • Appliquer de nouveau : • après 40 minutes de baignade ou après avoir transpire • immédiatement après s’être séché à la serviette • au moins toutes les 2 heures. Mesures de protection contre le soleil : Passer du temps au soleil augmente le risque de cancer de la peau et de vieillissement prématuré de la peau. Afin de diminuer ce risque, il convient d’utiliser régulièrement un écran solaire avec un F.P.S. à large spectre d’au moins 15 et d’appliquer d’autres mesures de protection contre le soleil, telles que : • limiter le temps passé au soleil, notamment entre 10 et 14 heures • porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil • Pour les enfants âgés de moins de 6 mois, consulter un médecin.

Other Information / Autres Renseignements

  • Protect the product in this container from excessive heat and direct sun. May stain surfaces and fabrics/ Tenir loin de la chaleur excessive ou des rayons de soleil. Peut tacher certains tissus et surfaces.

Inactive Ingredients / Ingrédients Inactifs

Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate / VP Copolymer, Aqua/Water/Eau, Bambusa Arundinacea Stem Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglycerides, Dilauryl Citrate, Ethylhexylglycerin, Ginkgo Biloba Leaf Extract, Gluconolactone, Glycine Soja (Soybean) Oil, Glycerin, Hydrogenated Methyl Abietate, Isopropyl Palmitate, Lauryl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-4 Laurate, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Lauryl Glucose Carboxylate, Sodium Phytate, Sodium Stearoyl Glutamate, Sorbitan Laurate, Tocopherol, Xanthan Gum.

Questions?

1-866-923-2665
Manufactured in Canada by/ Fabriqué au Canada par: Empack Spraytech Inc., 98 Walker Drive, Brampton, ON, L6T 4H6
UPC Please recycle (+ logo) Lot # and Expiry Date to be embossed on the tube seal

* Please review the disclaimer below.

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