NDC 51514-0354 Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin

Zinc Oxide, Titanium Dioxide

NDC Product Code 51514-0354

NDC Code: 51514-0354

Proprietary Name: Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin 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: Zinc Oxide, Titanium Dioxide 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
  • 51514 - Autumn Harp, Inc.
    • 51514-0354 - Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin

NDC Product Information

Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin with NDC 51514-0354 is a a human over the counter drug product labeled by Autumn Harp, Inc.. The generic name of Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Autumn Harp, 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 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.


Solaire Peau Parfaite 100% Mineral Fluid Flawless Skin 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.

  • TITANIUM DIOXIDE 2.5 mg/100mg
  • ZINC OXIDE 7.2 mg/100mg

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.

  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • BENTONITE (UNII: A3N5ZCN45C)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • SEA SALT (UNII: 87GE52P74G)
  • POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • LINGONBERRY (UNII: 0UNK9RZQ7X)
  • SQUALENE (UNII: 7QWM220FJH)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
  • KAKADU PLUM (UNII: 0ZQ1D2FDLI)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

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: Autumn Harp, Inc.
Labeler Code: 51514
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: 02-07-2019 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.

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

Otc - Active Ingredient

Titanium Dioxide 2.5%Zinc Oxide 7.2%

Uses

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.
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 exposureFor sunscreen use:reapply at least every 2 hoursuse a water-resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time
  • ​in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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-sleeved shirts, pants, hats, and sunglassesFor 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

Inactive Ingredients

Water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene*, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).* Botanically derived

Principle Display Panel

R12944_Tube_Approved_Proof_12.4.18.jpgR12945_03809 UnC PL Fluide 100 Mineral Zero Defaut FPS30 30ml zan_vs12.jpg

* Please review the disclaimer below.

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