NDC 58668-3320 Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots

Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone

NDC Product Code 58668-3320

NDC Code: 58668-3320

Proprietary Name: Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots Additional informationCallout TooltipWhat 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, Octisalate, Octocrylene, Oxybenzone Additional informationCallout TooltipWhat 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.


Code Structure
  • 58668 - Laboratoires Clarins
    • 58668-3320 - Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots

NDC 58668-3320-0

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC 58668-3320-1

Package Description: 1 TUBE in 1 CARTON > 5 mL in 1 TUBE

NDC 58668-3320-2

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots with NDC 58668-3320 is a a human over the counter drug product labeled by Laboratoires Clarins. The generic name of Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots is avobenzone, homosalate, octisalate, octocrylene, oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Laboratoires Clarins

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 Additional informationCallout TooltipWhat 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.


Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots Active Ingredient(s)

Additional informationCallout TooltipWhat 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 30 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 27 mg/mL
  • OXYBENZONE 60 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
  • MANNITOL (UNII: 3OWL53L36A)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PEA (UNII: W4X7H8GYFM)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires Clarins
Labeler Code: 58668
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots Product Label Images

Clarins Broad Spectrum Spf 50 Dry Touch Facial Sunscreen Enriched With Antioxidants Prevents Sun Induced Age Spots 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 3%HOMOSALATE 10%OCTISALATE 5%OCTOCRYLENE 2.7%OXYBENZONE 6%

Purpose

Sunscreen

Uses:

• helps prevent sunburn


• if used as directed with other sun protection measures (see


Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only.

Do 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


• apply to all skin exposed to the sun


• children under 6 months: Ask a doctor





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 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-sleeved shirts, pants, hats and sunglasses


• reapply at least every 2 hours


• use a water resistant sunscreen if swimming or sweating

Other Information:

• protect this product from excessive heat and direct sun

Inactive Ingredients

AQUA/WATER/EAU . C12-15 ALKYL BENZOATE . BUTYLOCTYL SALICYLATE . DIPROPYLENE GLYCOL DIBENZOATE . BUTYLENE GLYCOL . ALCOHOL . ALUMINUM STARCH OCTENYLSUCCINATE . ALOE BARBADENSIS LEAF JUICE . PPG-15 STEARYL ETHER BENZOATE . MANNITOL . CETEARYL ALCOHOL . PARFUM/ FRAGRANCE . POTASSIUM CETYL PHOSPHATE . GLYCERIN . PHENOXYETHANOL . ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER . CETEARYL GLUCOSIDE . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . XANTHAN GUM . TROMETHAMINE . TOCOPHEROL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE . BENZYL SALICYLATE . LIMONENE . BUTYLPHENYL METHYLPROPIONAL . HEXYL CINNAMAL . CITRONELLOL. [S1762A]

* Please review the disclaimer below.

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