NDC 62742-4204 Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30

Zinc Oxide

NDC Product Code 62742-4204

NDC 62742-4204-2

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 30 mL in 1 BOTTLE, PUMP (62742-4204-1)

NDC Product Information

Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30 with NDC 62742-4204 is a a human over the counter drug product labeled by Allure Labs. The generic name of Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Allure Labs

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.

Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30 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 189 mg/mL

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.

  • COCONUT ALKANES (UNII: 1E5KJY107T)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE (UNII: V5VD430YW9)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • WATER (UNII: 059QF0KO0R)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • BETASIZOFIRAN (UNII: 2X51AD1X3T)

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: Allure Labs
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: 05-03-2021 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.

Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30 Product Label Images

Eclipse Sheer Mineral Sunscreen Broad Spectrum Spf 30 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 IngredientsZinc Oxide 18.9%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

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 And Precautions

Warnings

• For external use only.

Otc - Do Not Use

Do Not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Dosage & Administration

Directions

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.Use a waterresistant sunscreen if swimming or sweating.

Other Safety Information

Other Information

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

Inactive Ingredient

Water (Aqua), Caprylic/Capric Triglyceride (plant-based conditioner), Coconut Alkanes (coconut-derived emollient), Cetearyl Alcohol (plant-derived fatty alcohol), Vegetable Glycerin, Aloe Leaf (Aloe barbadensis) Juice, Coco-Glucoside (plant-derived thickener), Cetearyl Glucoside (plant-derived emulsifier), Caprylyl/Capryl Glucoside (plant-based conditioner), Dipotassium Glycyrrhizate (licorice root-derived moisturizer), Green Tea (Camellia sinensis) Leaf Extract, Algae (Laminaria saccharina) Extract, Shea (Butyrospermum parkii) Butter, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate (plant-derived emulsifier), Polyhydroxystearic Acid (fatty acid), Polyglyceryl-3 Polyricinoleate (natural emulsifier), Isostearic Acid (plant-derived emollient), Sodium Phytate (natural stabilizer), Lecithin (plant-derived softener), Tocopherol (vitamin E), Xanthan Gum (plant-based stabilizer), Sclerotium Gum (plant-derived stabilizer), Glyceryl Caprylate (plant-derived emulsifier), Capryhydroxamic acid (plant-derived preservative)

* Please review the disclaimer below.