Soothe And Hydrate Starter Set
NDC 69378-009

View NDC Profile UNII Mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69378-009?
  5. Soothe And Hydrate Starter Set Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Soothe And Hydrate Starter Set is a OTC MONOGRAPH FINAL-approved product labeled by Acheson & Acheson Ltd.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 69378-009 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69378-009
Proprietary Name:
Soothe And Hydrate Starter Set
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Acheson & Acheson Ltd.
Labeler Code:
69378
Product Label ID:
d78476ae-4a90-2d19-e053-2a95a90af8de
FDA Application Number: [6]
part352
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
10-01-2021
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Product Characteristics

Color(s):
Pro-Collagen MarineBroad Spectrum SPF 30 (NDC 69378-001): WHITE (C48325)

Code Structure Chart

Product Details

What is NDC 69378-009?

The NDC code 69378-009 is assigned by the FDA to the product Soothe And Hydrate Starter Set. This pharmaceutical product is labeled by Acheson & Acheson Ltd. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69378-009-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

• apply liberally and evenly 15 minutes before sun exposure and as needed • children under 6 months of age: Ask a doctor • Sun Protection Measures.S pending time in the sun increases your risk of skin cancer and early skin ageing, To decrease this risk, regularly use a sunscreen with a Broad SpectrumS PF value of 15 or higher and other sun protection measures including· limit time in the sun, especially from 1 0a.m. - 2 p.m. • wear long-sleeved shirts. pants. hats. and sunglasses• reapply at least every 2 hours• use a water resistant sunscreen if swimming or sweating

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".