NDC 71585-120 Sunscreen Lip Balm Spf 30

Zinc Oxide

NDC Product Code 71585-120

NDC Product Information

Sunscreen Lip Balm Spf 30 with NDC 71585-120 is a a human over the counter drug product labeled by Salt And Stone Llc. The generic name of Sunscreen Lip Balm Spf 30 is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Salt And Stone Llc

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.

Sunscreen Lip Balm 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 80 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.

  • ALMOND OIL (UNII: 66YXD4DKO9)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • JOJOBA OIL (UNII: 724GKU717M)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)

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: Salt And Stone Llc
Labeler Code: 71585
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: 06-15-2019 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: 12-31-2020 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.

Sunscreen Lip Balm Spf 30 Product Label Images

Sunscreen Lip Balm 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

Active Ingredients:

Non-Nano Zinc Oxide 8%

Purpose:

Sunscreen

Uses:

Helps Prevent Sunburn

Warnings:

• For external use only

Do Not Use

  • On damaged or broken skin

Stop Use And Ask A Doctor If

• Rash occurs

When Using This Product

• Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center right away.

Directions:

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours 
• Children under 6 months of age: Ask a doctor.Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value 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.

Inactive Ingredients:

Prunus Amygdalus Dulcis (Sweet Almond) Oil*, Butyrospermum Parkii (Shea) Butter*, Cera Alba (Beeswax)*, Simmondsia Chinensis (Jojoba) Seed Oil*, Caprylic/capric Triglyceride, Euphorbia Cerifera (Candelilla) Wax*, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil*, Copernicia Cerifera (Carnauba) Wax*, Tocopherol, Bisabolol, Glyceryl Caprylate, Isostearic Acid, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Glyceryl Undecylenate. *Organic Ingredient.

Other Information:

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.

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