NDC 64768-2926 Mustela Mineral Sunscreen Spf 50

Zinc Oxide

NDC Product Code 64768-2926

NDC 64768-2926-1

Package Description: 1 TUBE in 1 CARTON > 17 g in 1 TUBE

NDC Product Information

Mustela Mineral Sunscreen Spf 50 with NDC 64768-2926 is a a human over the counter drug product labeled by Expanscience Laboratories D/b/a Mustela. The generic name of Mustela Mineral Sunscreen Spf 50 is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Expanscience Laboratories D/b/a Mustela

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Mustela Mineral Sunscreen Spf 50 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 197 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.

  • CHAMOMILE (UNII: FGL3685T2X)
  • PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • ORYZANOL (UNII: SST9XCL51M)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • TAMANU OIL (UNII: JT3LVK84A1)
  • NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • JOJOBA OIL (UNII: 724GKU717M)
  • FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • RICE BRAN OIL (UNII: LZO6K1506A)
  • OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Expanscience Laboratories D/b/a Mustela
Labeler Code: 64768
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: 01-25-2021 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 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.

Mustela Mineral Sunscreen Spf 50 Product Label Images

Mustela Mineral Sunscreen Spf 50 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 Ingredient

Zinc Oxide 19.7%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Higher SPF gives more sunburn protectionRetains SPF after 80 minutes of activity in the water

Warnings

For external use only

Do Not Use

On damaged or broken skin

Stop Use And Ask A Doctor

If rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center right away.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Directions

  • Apply liberally 15 minutes before sun exposureReapply: after 80 minutes of swimming or sweatingimmediately after towel dryingat 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, 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 - 2p.mwear long-sleeved shirt, pants, hat, and sunglasseschildren under 6 months: ask a doctor.

Inactive Ingredients

ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, EUPHORBIA CERIFERA (CANDELILLA) WAX, OCTYLDODECYL OLEATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, BEESWAX*, THEOBROMA CACAO (COCOA) SEED BUTTER*, ORYZANOL, JOJOBA ESTERS, BUTYROSPERMUM PARKII (SHEA) BUTTER*, BISABOLOL*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, PUERARIA LOBATA ROOT EXTRACT*, SPIRAEA ULMARIA FLOWER EXTRACT*, TOCOPHEROL*CERTIFIED ORGANIC INGREDIENTS

Other Information

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Company Information

MADE IN THE USA from globally sourced materials for

Expanscience Laboratories Inc.,

Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022

www.MustelaUSA.com

* Please review the disclaimer below.