NDC 65692-0566 Broad Spectrum Spf 30 Sunscreen

Broad Spectrum Spf 30 Sunscreen

NDC Product Code 65692-0566

NDC CODE: 65692-0566

Proprietary Name: Broad Spectrum Spf 30 Sunscreen 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: Broad Spectrum Spf 30 Sunscreen 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.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

  • 65692 - Raining Rose

NDC 65692-0566-1

Package Description: 44 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Broad Spectrum Spf 30 Sunscreen with NDC 65692-0566 is a a human over the counter drug product labeled by Raining Rose. The generic name of Broad Spectrum Spf 30 Sunscreen is broad spectrum spf 30 sunscreen. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Raining Rose

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.

Broad Spectrum Spf 30 Sunscreen 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 8.25 g/44mL

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.

  • WHITE WAX (UNII: 7G1J5DA97F)
  • JOJOBA OIL (UNII: 724GKU717M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • 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: Raining Rose
Labeler Code: 65692
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: 05-13-2021 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.

Broad Spectrum Spf 30 Sunscreen Product Label Images

Broad Spectrum Spf 30 Sunscreen 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

Active Ingredients:Zinc Oxide (18.75%) Non-nanoparticle

Purpose:

Sunscreen

Uses:

  • Helps prevent sunburn

Warnings:

  • For external use onlyDo not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of readh of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureReapply after 80 minutes of swimming or sweatingReapply immediately after towel dryingReapply at least every 2 hoursChildren under 6 months of age: Ask a doctorSun 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 10a.m.-2p.m.wear long sleeved shirts, pants, hats and sunglasses.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Sunflower Oil*, Beeswax*, Jojoba Oil*, Coconut Oil*, Tocopherol (Non-GMO). *Organic

* Please review the disclaimer below.