NDC 70983-024 Sun Guard

Zinc Oxide

NDC Product Code 70983-024

NDC Product Information

Sun Guard with NDC 70983-024 is a a human over the counter drug product labeled by Saje Natural Business Inc. The generic name of Sun Guard is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Saje Natural Business 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.

Sun Guard 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 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.

  • HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)
  • ROSEMARY (UNII: IJ67X351P9)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • SANDALWOOD OIL (UNII: X7X01WMQ5F)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • CHAMOMILE (UNII: FGL3685T2X)

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: Saje Natural Business Inc
Labeler Code: 70983
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: 05-09-2019 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.

Sun Guard 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

Zinc Oxide 20%

Otc - Purpose

Sunscreen

Indications & Usage

Helps protect against sunburn.

Warnings

For external use only.Do not use if foil seal is broken or missing

Otc - Do Not Use

Do not use • on damaged or broken skin • if you are pregnant or breastfeeding • if you are allergic to plants in the Asteraceae/Compositae/Daisy family

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove

Otc - Ask Doctor

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.

Dosage & Administration

Directions • Apply liberally and evenly 15 minutes before sun exposure • Children under 6 months of age: ask a doctor • Reapply as needed or after towel drying, swimming or sweating. • Reapply at least every 2 hours • Use water resistant sunscreen if swimming or sweating.

Other Safety Information

• Protect the product in this container from excessive heat and direct sun. •
Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
Questions? 1-877-275-7253
distributed by : saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness made by our friends in canada

Inactive Ingredient

Anthemis nobilis flower oil, beeswax (white), calendula officinalis flower, chamomilla recutita (matricaria) flower extract, daucus carota sativa (carrot) seed oil, hippophae rhamnoides fruit extract, olive oil, pelargonium graveolens oil, rosmarinus officinalis (rosemary) leaf extract , santalum album (sandalwood) oil, soybean oil, sunflower oil, vitamin e.

Description

SPF 30 Broad-Spectrum Sunscreen Lotion

3.4 fl. oz. | 100ml

6.1 fl. oz. | 180 ml

* Please review the disclaimer below.

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