NDC 66800-4087 Coppertone Tanning Sunscreen Spf 15

Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

NDC Product Code 66800-4087

NDC CODE: 66800-4087

Proprietary Name: Coppertone Tanning Sunscreen Spf 15 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: Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3% 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 - WHITE TO OFF-WHITE)

NDC Code Structure

  • 66800 - Beiersdorf Inc
    • 66800-4087 - Coppertone Tanning Sunscreen Spf 15

NDC 66800-4087-1

Package Description: 237 g in 1 BOTTLE, PLASTIC

NDC Product Information

Coppertone Tanning Sunscreen Spf 15 with NDC 66800-4087 is a a human over the counter drug product labeled by Beiersdorf Inc. The generic name of Coppertone Tanning Sunscreen Spf 15 is avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3%. 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.

Coppertone Tanning Sunscreen Spf 15 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.

  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ISODODECANE (UNII: A8289P68Y2)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
  • ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • POLYESTER-7 (UNII: 0841698D2F)

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: Beiersdorf Inc
Labeler Code: 66800
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: 12-20-2021 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".

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Coppertone Tanning Sunscreen Spf 15 Product Label Images

Coppertone Tanning Sunscreen Spf 15 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

Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

Purpose

Sunscreen

Use

■ helps prevent sunburn

Warnings

For external use onlyDo not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply liberally 15 minutes before sun exposure■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours■ children under 6 months: Ask a doctor

Other Information

■ protect this product from excessive heat and direct sun■ may stain or damage some fabrics or surfaces

Inactive Ingredients

Water, aluminum starch octenylsuccinate, glycerin, silica, phenoxyethanol, isododecane, ethylhexylglycerin, polyester-27, styrene/acrylates copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl alcohol, neopentyl glycol diheptanoate, glyceryl stearate, PEG-100 stearate, tocopherol, beeswax, fragrance, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

* Please review the disclaimer below.