NDC 82365-5550 Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection

Octinoxate And Zinc Oxide

NDC Product Code 82365-5550

NDC CODE: 82365-5550

Proprietary Name: Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection 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: Octinoxate And Zinc Oxide 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

  • 82365 - Saguaro Dermatology Associates, L.l.c.
    • 82365-5550 - Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection

NDC 82365-5550-2

Package Description: 50 g in 1 BOTTLE, PLASTIC

NDC Product Information

Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection with NDC 82365-5550 is a a human over the counter drug product labeled by Saguaro Dermatology Associates, L.l.c.. The generic name of Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection is octinoxate and zinc oxide. The product's dosage form is cream and is administered via topical form.

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.

Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • ISOCETYL STEARATE (UNII: 3RJ7186O9W)
  • SORBITOL (UNII: 506T60A25R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ALCOHOL (UNII: 3K9958V90M)
  • OCTISALATE (UNII: 4X49Y0596W)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BETULA PUBESCENS BARK (UNII: 3R504894L9)
  • GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
  • SAGE (UNII: 065C5D077J)
  • COLA ACUMINATA SEED (UNII: 1F8VIW1479)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ISOMALT (UNII: S870P55O2W)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Saguaro Dermatology Associates, L.l.c.
Labeler Code: 82365
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: 11-01-2021 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.

Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection Product Label Images

Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection 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

Other

DRUG FACTS

Active Ingredients

Octinoxate 7.5%Zinc Oxide 4.8%

Purpose

Sunscreen

Uses

Help prevent sunburn.

Warnings

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 or irritation 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.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • For children under 6 months of age: Ask a doctor.Reapply:
  • At least 80 minutes after swimming or sweating, immediately after towel drying, at 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. – 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

Other Information

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Saguaro Dermatology Dynamic Sunscreen Broad Spectrum Spf 55 Sun Protection 1.75 Fl Oz (50Ml)

Saguaro Dermatology

Dynamic Sunscreen Broad Spectrum SPF 55

Sun Protection

1.75 fl oz (50ml)

* Please review the disclaimer below.