NDC 72098-003 Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen

Zinc Oxide, Titanium Dioxide

NDC Product Code 72098-003

NDC CODE: 72098-003

Proprietary Name: Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen 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: Zinc Oxide, Titanium Dioxide 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

  • 72098 - Everyday Group Limited
    • 72098-003 - Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen

NDC 72098-003-04

Package Description: 43 mL in 1 TUBE

NDC Product Information

Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen with NDC 72098-003 is a a human over the counter drug product labeled by Everyday Group Limited. The generic name of Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Everyday Group Limited

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.

Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen 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 112.5 mg/mL
  • TITANIUM DIOXIDE 15 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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • ANHYDROXYLITOL (UNII: 8XWR7NN42F)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
  • XYLITOL (UNII: VCQ006KQ1E)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Everyday Group Limited
Labeler Code: 72098
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: 05-18-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen Product Label Images

Rose Sil Vous Plait Spf30 Gentle Mineral Sunscreen 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

Zinc Oxide 11.25%Titanium Dioxide 1.50%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early signs of 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 swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally 15 minutes before sun exposureReapply:After 80 minutes of swimming or sweatingImmediately after towel drying At least every 2 hoursSun 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. to 2 p.m.Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Water (Aqua), Organic Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Coconut Alkanes, Coco-Caprylate, Cetearyl Glucoside, Cetyl Palmitate, Galactoarabinan, Rosa Centifolia Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Sorbitan Oleate, Sorbitan Palmitate, Anhydroxylitol, Coco-Caprylate/Caprate, Xylitylglucoside, Xylitol, Glyceryl Isostearate, Polyhydroxystearic Acid, Tocopherol, Sorbitan Isostearate, Caprylyl/Capryl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Jojoba Esters, Phenoxyethanol, Benzyl Alcohol.

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

* Please review the disclaimer below.