NDC 62742-4192 Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32

Zinc Oxide

NDC Product Code 62742-4192

NDC 62742-4192-2

Package Description: 1 TUBE in 1 CARTON > 48 g in 1 TUBE (62742-4192-1)

NDC Product Information

Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32 with NDC 62742-4192 is a a human over the counter drug product labeled by Allure Labs Inc. The generic name of Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Allure Labs 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.

Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32 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 210 mg/g

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)
  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • STARCH, RICE (UNII: 4DGK8B7I3S)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)
  • SUCROSE (UNII: C151H8M554)
  • PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • C8-10 ALCOHOLS (UNII: 6X61I5U3A4)

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: Allure Labs Inc
Labeler Code: 62742
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: 11-03-2020 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.

Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32 Product Label Images

Daily Spf Facial Sunscreenlotion Broad Spectrum Spf 32 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

Otc - Active Ingredient

Active Ingredients:Zinc Oxide 21%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

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

Warnings And Precautions

Warning: For external use only.

Otc - Do Not Use

Do not use: on damaged or broken skin.

Otc - When Using

When using this products: Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor: If rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: If product is swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directions: Apply generously 15 minutes before sun exposer. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protection measures: Spending time in the sun increase 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 10am - 2pm.Wear long sleeved shirts, pants, hats and sunglasses.

Other Safety Information

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

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Helianthus annuus (sunflower) seed oil, Coco-Glucoside, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Cetearyl Glucoside, Xanthan Gum, Coco-Caprylate/Caprate, Lecithin, Caprylyl/Capryl Glucoside, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Oryza Sativa Starch, Dipotassium Glycyrrhizate, Bisabolol, Caprylhydroxamic Acid, Sodium Pthalate, Sclerotium Gum, Sucrose, Phaeodactylum Tricornutum Extract, Glucose, Spirulina Maxima Extract, Tocopherol, C10 Alochol, C8 Alcohol.

* Please review the disclaimer below.