NDC 70060-1901 Ultra Replenishing Sunscreen Spf 40

Homosalate, Octisalate, Octocrylene, Zinc Oxyide Cream

NDC Product Code 70060-1901

NDC Code: 70060-1901

Proprietary Name: Ultra Replenishing Sunscreen Spf 40 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Homosalate, Octisalate, Octocrylene, Zinc Oxyide Cream What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 70060-1901-1

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 70060-1901-2

Package Description: 1.5 mL in 1 PACKET

NDC Product Information

Ultra Replenishing Sunscreen Spf 40 with NDC 70060-1901 is a a human over the counter drug product labeled by Cosmedical Technologies, Llc. The generic name of Ultra Replenishing Sunscreen Spf 40 is homosalate, octisalate, octocrylene, zinc oxyide cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cosmedical Technologies, Llc

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.

Ultra Replenishing Sunscreen Spf 40 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.

  • HOMOSALATE 4 mg/50mL
  • OCTOCRYLENE 2.5 mg/50mL
  • ZINC OXIDE 4 mg/50mL
  • OCTISALATE 2.5 mg/50mL

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.

  • STEARETH-2 (UNII: V56DFE46J5)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARETH-21 (UNII: 53J3F32P58)
  • MICA (UNII: V8A1AW0880)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
  • VANILLA (UNII: Q74T35078H)
  • DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • JOJOBA OIL (UNII: 724GKU717M)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)
  • WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
  • ORANGE OIL (UNII: AKN3KSD11B)

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: Cosmedical Technologies, Llc
Labeler Code: 70060
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: 09-16-2019 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.

Ultra Replenishing Sunscreen Spf 40 Product Label Images

Ultra Replenishing Sunscreen Spf 40 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

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc Oxide 8%

Otc - Purpose

Sunscreen

Inactive Ingredient

Water

C12-15 Alkyl Benzoate

Glycerin

Mica

Polyglyceryl-2 Stearate

Glyceryl Stearate

Steareth-21

Stearyl Alcohol

Dimethicone

Phenoxyethanol

Simmondsia Chinensis (Jojoba) Seed Oil

Steareth-2

Fructose

Cocos Nucifera (Coconut) Oil

Citric Acid

Ethylhexylglycerin

Hydroxyethylcellulose

Chlorphenesin

Hydrolyzed Rice Protein

Titanium Dioxide (CI 77891)

Tocopheryl Acetate

Kaempferia Galanga Root Extract

Aloe Barbadensis Leaf Juice

Sodium Phytate

Lavandula Angustifolia (Lavender) Oil

Withania Somnifera Flower Extract

Iron Oxide (CI 77492)

Iron Oxide (CI 77491)

Citrus Aurantium Dulcis (Orange) Peel Oil

Silica

Dimethylmethoxy Chromanol

Vanilla Planifolia Fruit Extract

Iron Oxide (CI 77499)

Warnings And Precautions

Warnings

For external use only.

Do not use on damaged or broken skin.

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

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.

Dosage & Administration

Directions

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply: at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating.

• 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.–2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

* Please review the disclaimer below.