NDC 73517-382 Pipette Mineral Sunscreen Broad Spectrum Spf50

Zinc Oxide

NDC Product Code 73517-382

NDC 73517-382-01

Package Description: 120 mL in 1 TUBE

NDC 73517-382-02

Package Description: 30 mL in 1 TUBE

NDC 73517-382-03

Package Description: 15 mL in 1 TUBE

NDC Product Information

Pipette Mineral Sunscreen Broad Spectrum Spf50 with NDC 73517-382 is a a human over the counter drug product labeled by Amyris, Inc. The generic name of Pipette Mineral Sunscreen Broad Spectrum Spf50 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Amyris, 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.

Pipette Mineral Sunscreen Broad Spectrum Spf50 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 20 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SQUALANE (UNII: GW89575KF9)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • ETHYL FERULATE (UNII: 5B8915UELW)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM GLUCONATE (UNII: R6Q3791S76)
  • BISABOLOL OXIDE A (UNII: 16AE65F94Y)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • HEXANEDIOL (UNII: ZIA319275I)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHYSALIS ANGULATA (UNII: W4TKW9D5GG)

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: Amyris, Inc
Labeler Code: 73517
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-01-2020 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pipette Mineral Sunscreen Broad Spectrum Spf50 Product Label Images

Pipette Mineral Sunscreen Broad Spectrum Spf50 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 20%

Purpose

Sunscreen

Uses

Helps prevent sunburnif used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

Warnings

For external use only

Do Not Use

On damaged of 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

  • Apply generously 15 minutes before sun exposurereapply at least  every 2 hours​Sun Protection Measures   ​Spending time in the sun increases your risk of skin cancer and early skin aging.   To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 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 shiirts, pants, hats and sunglassesuse a water-resistant sunscreen if swimming or sweatingchildren under 6 months of age:ask a doctor.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Bisabolol, Hydroxyacetophenone, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, 1,2-Hexandiol, Caprylyl Glycol, Physalis Angulata Extract, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate.

* Please review the disclaimer below.