NDC 64760-720 Glytone Mineral Sunscreen Spf 40

Zinc Oxide, Titanium Dioxide

NDC Product Code 64760-720

NDC 64760-720-01

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Glytone Mineral Sunscreen Spf 40 with NDC 64760-720 is a a human over the counter drug product labeled by Pierre Fabre Usa Inc.. The generic name of Glytone Mineral Sunscreen Spf 40 is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Pierre Fabre Usa 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.

Glytone Mineral Sunscreen Spf 40 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 2 mg/50mL
  • ZINC OXIDE 1 mg/50mL

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.

  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • .BETA.-BISABOLOL (UNII: LP618AV2EA)
  • APPLE FRUIT OIL (UNII: 9NT987I3A8)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • SODIUM ASCORBATE (UNII: S033EH8359)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ALPHA-TOCOPHEROL, L- (UNII: 82190DH9F2)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
  • POLYESTER-7 (UNII: 0841698D2F)
  • C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)
  • LOCUST BEAN GUM (UNII: V4716MY704)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • SQUALANE (UNII: GW89575KF9)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)

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.
  • 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: Pierre Fabre Usa Inc.
Labeler Code: 64760
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: 07-02-2020 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.

Glytone Mineral Sunscreen Spf 40 Product Label Images

Glytone Mineral Sunscreen Spf 40 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 Ingredients

Titanium Dioxide 2%Zinc Oxide 1%

Uses

  • Helps prevent sunburn.If used as directed with other sun protection measures (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Directions

  • Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweating.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 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-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol, Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotlum Gum, Dimethiconol/Octylsilsesquioxane/Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate. Pullulan. Xanthan Gum, Sodium Hyaluronate, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer

Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Sodium Ascorbate, Potassium Sorbate, Tocopherol.

* Please review the disclaimer below.