NDC 68062-9001 Moisture Sunscreen Spf 50

Titanium Dioxide, Zinc Oxide

NDC Product Code 68062-9001

NDC 68062-9001-1

Package Description: 120 mL in 1 TUBE

NDC Product Information

Moisture Sunscreen Spf 50 with NDC 68062-9001 is a a human over the counter drug product labeled by Spa De Soleil. The generic name of Moisture Sunscreen Spf 50 is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

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.

Moisture Sunscreen Spf 50 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.

  • HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCONUT OIL (UNII: Q9L0O73W7L)

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: Spa De Soleil
Labeler Code: 68062
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: 09-09-2021 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.

Moisture Sunscreen Spf 50 Product Label Images

Moisture Sunscreen Spf 50 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

Zinc Oxide 9.5%Octinoxate 7.5%

Purpose

Sunscreen

Warnings

  • Warnings When using this product
  • Keep out of the eye arearinse with water to removestop use and ask a doctor if rash or irritation developsfor external use onlylkeep out of reach of children

Directions

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.Children under six months of age: Consult a doctor.

Inactive Ingredients

Aqua, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Polyglyceryl-6 Distearate, Glyceryl Stearate, Titanium Dioxide, PEG-100 Stearate, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Disodium EDTA, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Ascorbic Acid (Vitamin C),

* Please review the disclaimer below.