NDC 66800-4744 Coppertone Pure And Simple Sunscreen Spf 50

Zinc Oxide 24.08%

NDC Product Code 66800-4744

NDC 66800-4744-5

Package Description: 142 g in 1 CAN

NDC 66800-4744-6

Package Description: 142 g in 1 CAN

NDC 66800-4744-7

Package Description: 142 g in 1 CAN

NDC Product Information

Coppertone Pure And Simple Sunscreen Spf 50 with NDC 66800-4744 is a a human over the counter drug product labeled by Beiersdorf Inc. The generic name of Coppertone Pure And Simple Sunscreen Spf 50 is zinc oxide 24.08%. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Beiersdorf Inc

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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 Pure And Simple 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.

  • ZINC OXIDE 240.8 mg/g

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • POLYESTER-7 (UNII: 0841698D2F)
  • ISOBUTANE (UNII: BXR49TP611)
  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
  • SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)

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: 01-01-2021 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: 12-31-2021 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.

Coppertone Pure And Simple 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

Drug Facts

Drug Facts

Active Ingredient

Active ingredients(To Deliver) Zinc Oxide 24.08%

Purpose

PurposeSunscreen

Use

Usehelps prevent sunburn

Warnings

WarningsFor external use onlyFlammable: Do not use near heat, flame, or while smoking
Do not use on damaged or broken skin
When using this product
■ keep away from face to avoid breathing it
■ keep out of eyes. Rinse with water to remove.■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.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

Directions■ shake well before each use■ spray liberally and spread evenly by hand 15 minutes before sun exposure■ hold container 4 to 6 inches from the skin to apply■ do not spray directly into face. Spray on hands then apply to face.■ do not apply in windy conditions■ use in a well-ventilated area■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours■
Sun 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 10 a.m. – 2 p.m. ■ wear long-sleeve shirts, pants, hats, and sunglasses■ children under 6 months: Ask a doctor

Other Information

Other Information■ protect this product from excessive heat and direct sun■ store between 20˚ to 25˚C (68˚ to 77˚F)■ may stain or damage some fabrics or surfaces

Inactive Ingredients

Inactive ingredients isobutane, water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, caprylyl methicone, sodium chloride, cetyl dimethicone

Questions

Questions? 1-866-288-3330

* Please review the disclaimer below.