NDC 66846-015 Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30

Avobenzone, Homosalate, Octinoxate, Octisalate

NDC Product Code 66846-015

NDC Code: 66846-015

Proprietary Name: Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 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, Homosalate, Octinoxate, Octisalate 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.

NDC Code Structure

  • 66846 - Codif International
    • 66846-015 - Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30

NDC 66846-015-01

Package Description: 50 mL in 1 TUBE

NDC 66846-015-04

Package Description: 125 mL in 1 TUBE

NDC Product Information

Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 with NDC 66846-015 is a a human over the counter drug product labeled by Codif International. The generic name of Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 is avobenzone, homosalate, octinoxate, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Codif International

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 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.

  • AVOBENZONE 27 mg/mL
  • HOMOSALATE 70 mg/mL
  • OCTINOXATE 67 mg/mL
  • OCTISALATE 45 mg/mL

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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SEA SALT (UNII: 87GE52P74G)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)

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: Codif International
Labeler Code: 66846
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: 03-15-2019 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: 12-31-2020 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.

Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 Product Label Images

Soleil Sun Creme Solaire Visage Et Corps Sunscreen Face And Body Sunscreen Broad Spectrum Spf30 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 2.7%





Homosalate 7%





Octinoxate 6.7%





Octisalate 4.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.if used as directed with other sun protection measures (see Directions), decreases the risk of sun cancer and early skin aging caused by the sun.

Warnings

For external use only

Do Not Use

On damaged skin 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 exposurereapply at least every two hoursuse a water resistant sunscreen if swimming or sweatingSun protections measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly use a sunscreen with a broad spectrum SPF 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 sunglasseschildren under 6 months: Ask a doctor

Other Information

  • Protect this product from excessive
  • Heat and direct sun

Inactive Ingredients

Water, butyloctyl salicylate, ethylhexyl methoxycrylene, dicaprylyl carbonate, butylene glycol cocoate, glycerin, polyglyceryl-6 distearate, styrene/acrylates copolymer, jojoba esters, dimethicone, phenoxyethanol, potassium cetyl phosphate, fragrance, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, polyglyceryl-3 beeswax, xanthan gum, cetyl alcohol, chlorphenesin, peg-8 laurate, dimethiconol, 1,2-hexanediol, caprylyl glycol, disodium edta, polysorbate 60, sorbitan isostearate, sea salt, bht, tocopherol.

* Please review the disclaimer below.

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