NDC 63505-354 Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin

Titanium Dioxide, Zinc Oxide

NDC Product Code 63505-354

NDC Code: 63505-354

Proprietary Name: Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin 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: Titanium Dioxide, Zinc Oxide 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.


Code Structure
  • 63505 - Yves Rocher Amerique Du Nord Inc
    • 63505-354 - Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin

NDC 63505-354-00

Package Description: 1 TUBE in 1 BOX > 30 mL in 1 TUBE

NDC Product Information

Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin with NDC 63505-354 is a a human over the counter drug product labeled by Yves Rocher Amerique Du Nord Inc. The generic name of Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Yves Rocher Amerique Du Nord Inc

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.


Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin 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.

  • TITANIUM DIOXIDE 25 mg/mL
  • ZINC OXIDE 72 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.

  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • BENTONITE (UNII: A3N5ZCN45C)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
  • OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • SQUALENE (UNII: 7QWM220FJH)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Yves Rocher Amerique Du Nord Inc
Labeler Code: 63505
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: 05-01-2019 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.

Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin Product Label Images

Solaire Peau Parfaite 100 Mineral Fluid Flawless Skin 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

Titanium Dioxide 2.5%,


Zinc Oxide 7.2%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

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.

Discontinue Use And Ask A Doctor

If rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply generously and evenly every morning on cleansed face and neck 15 minutes before sun exposure 
• For sunscreen use : • reapply at least every 2 hours. • use a water- resistant sunscreen if swimming or sweating. • 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 am - 2 pm • wear hats and sunglasses. • For use on children less than 6 months of age, consult a doctor.

Other Information

  • Protect the product in this container from excessive heat and direct sun. • Store at 15-30°C (59-86°F)

Inactive Ingredients

Water/Eau, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Diisopropyl Sebacate, Isononyl Isononanoate, Polyglyceryl-6 Polyricinoleate, Polymethylsilsesquioxane, Glycerin, Argania Spinosa Kernel Oil, Polyglyceryl-2 Isostearate, Tocopheryl Acetate,  Silica,  Phenoxyethanol, Disteardimonium Hectorite, Polyhydroxystearic Acid, Hydrogenated Castor Oil, Sodium Chloride, Magnesium Stearate, Bisabolol, Aloe Barbadensis Leaf Juice Powder, Alumina, Isopropyl Myristate, Raspberry Seed Oil Tocopheryl Succinate Aminopropanediol Esters, Caesalpinia Spinosa Fruit Extract, Bentonite, Vaccinium Vitis-Idaea Fruit Extract, Kappaphycus Alvarezii Extract, Hydrolyzed Pea Protein, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Olive Oil Decyl Esters, Tocopherol, Citric Acid, Hydrated Silica, Propylene Carbonate, Lactic Acid, Terminalia Ferdinandiana Fruit Extract, Saccharide Isomerate, Squalene*, Xanthan Gum, Potassium Sorbate, Gluconolactone, Chlorella Vulgaris Extract, Sodium Benzoate, Sea Salt/Sel Marin, Calcium Gluconate, Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891). * Botanically derived • Dérivé de plantes

Questions?

Call : CAN 1-800-361-2746 / USA 1 - 800-321-3434.

* Please review the disclaimer below.

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