NDC 52667-012 100% Pure Green Tea Spf 30 Sunscreen

Zinc Oxide

NDC Product Information

100% Pure Green Tea Spf 30 Sunscreen with NDC 52667-012 is a a human over the counter drug product labeled by Purity Cosmetics. The generic name of 100% Pure Green Tea Spf 30 Sunscreen is zinc oxide. The product's dosage form is lotion and is administered via topical form.

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.

100% Pure Green Tea 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.


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.

  • SUCROSE COCOATE (UNII: 3H18P0UK73)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
  • CARROT (UNII: L56Z1JK48B)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)
  • PHOSPHATE ION (UNII: NK08V8K8HR)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
  • WATER (UNII: 059QF0KO0R)
  • ISOAMYL LAURATE (UNII: M1SLX00M3M)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • SESAME OIL (UNII: QX10HYY4QV)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SAFFLOWER SEED (UNII: 8FCL6A31TX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • BETA CAROTENE (UNII: 01YAE03M7J)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Purity Cosmetics
Labeler Code: 52667
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: 08-30-2021 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: 12-31-2022 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.

100% Pure Green Tea Spf 30 Sunscreen Product Label Images

100% Pure Green Tea 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

Purpose:

Sunscreen

Active Ingredient:

Zinc Oxide 210mg/g

Uses:

Moisturizes while protecting against sun’s UVA+UVB rays

Warnings:

• Skin cancer/Skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging • 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:

After cleansing and toning, apply liberally 30 minutes before sun exposure to face, neck, and all other exposed areas. Reapply every 2 hours and after swimming, sweating, or towel drying.

Other Ingredients:

Aqua, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Cetearyl Glucoside, Polyhydroxystearic Acid, Glycine Soja (Soybean) Oil, Sucrose Cocoate, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sesamum Indicum (Sesame) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Persea Gratissima (Avocado) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hip) Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis (Green Tea) Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Beta-Carotene, Tocopherol (Vitamin E)

Other Information

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

* Please review the disclaimer below.