NDC 81341-0600 Tinted Mineral Defense Broad Spectrum Spf 30 Sunscreen

Titanium Dioxide And Zinc Oxide

NDC Product Code 81341-0600

NDC 81341-0600-2

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Tinted Mineral Defense Broad Spectrum Spf 30 Sunscreen with NDC 81341-0600 is a a human over the counter drug product labeled by Pura Vida Body & Mind Spa, Inc.. The generic name of Tinted Mineral Defense Broad Spectrum Spf 30 Sunscreen is titanium dioxide and zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pura Vida Body & Mind Spa, Inc.

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.

Tinted Mineral Defense Broad Spectrum Spf 30 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.

  • TITANIUM DIOXIDE 7.75 g/100mL
  • ZINC OXIDE 10 g/100mL

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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
  • SQUALANE (UNII: GW89575KF9)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • JOJOBA OIL (UNII: 724GKU717M)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • 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: Pura Vida Body & Mind Spa, Inc.
Labeler Code: 81341
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: 12-30-2020 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 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.

Tinted Mineral Defense Broad Spectrum Spf 30 Sunscreen Product Label Images

Tinted Mineral Defense Broad Spectrum Spf 30 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

Other

DRUG FACTS:

Active Ingredients

Titanium Dioxide 7.75%, Zinc Oxide 10.0%.

Purpose

Sunscreen

Uses

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.


Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: 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 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 sunglasses.

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Tocopheryl Acetate, Perilla Frutescens Extract, Vitis Vinifera Fruit Cell Extract, Lepidium Sativum Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499).

Other Information

Protect the product in this container from excessive heat and direct sun.

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