NDC 62742-4199 Sheer Zinc Spf 30

Zinc Oxide

NDC Product Code 62742-4199

NDC Product Information

Sheer Zinc Spf 30 with NDC 62742-4199 is a a human over the counter drug product labeled by Allure Labs Inc.. The generic name of Sheer Zinc Spf 30 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.

Sheer Zinc 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 186 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.

  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • BUTYL CYANOACETATE (UNII: F9H6L20VOH)
  • HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • LAURETH-7 (UNII: Z95S6G8201)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • DATE (UNII: H3O7QI5HY7)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • TEPRENONE (UNII: S8S8451A4O)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
  • CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

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 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: 12-17-2020 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.

Sheer Zinc Spf 30 Product Label Images

Sheer Zinc 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 18.6%

Otc - Purpose

Purpose:Sunscreen

Indications & Usage

  • Uses: Helps prevent Sunburn.If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early aging caused by sun.

Warnings

  • Warnigs:For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product 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 liberally 15 minutes before sun exposure. Children under 6 months of age: Ask a DoctorReapply at least every 2 hours.

Other Safety Information

  • Other InformationProtect the product in this container from excessive heat and direct sun.

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Cyclopentasiloxane , Butylene Glycol, Glycerin , Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone , Cyclohexasiloxane , Dimethicone , Sorbitan Stearate , Caprylic/Capric Triglyceride, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol , Lecithin , Tocopherol , Ascorbyl Palmitate, Ascorbic Acid, Citric Acid , Xanthan Gum, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract , Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract , Micrococcus Lysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer , Tetrahexyldecyl Ascorbate , Bis(Cyano Butylacetate) Anthracenediylidene, Propylene Glycol , Caesalpinia spinosa Fruit Pod Extract , Helianthus Annuus(Sunflower) Sprout Extract, Sodium Benzoate , Potassium Sorbate, Rosa Damascena Flower Extract , 1,2-Hexanediol

* Please review the disclaimer below.