NDC 82281-239 Stryx Daily Moisturizer Spf-30

Octisalate, Ensulizole

NDC Product Code 82281-239

NDC 82281-239-00

Package Description: 100 mL in 1 TUBE

NDC Product Information

Stryx Daily Moisturizer Spf-30 with NDC 82281-239 is a a human over the counter drug product labeled by Stryx Men, Inc.. The generic name of Stryx Daily Moisturizer Spf-30 is octisalate, ensulizole. 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.

Stryx Daily Moisturizer 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • AVOBENZONE (UNII: G63QQF2NOX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • APPLE (UNII: B423VGH5S9)
  • OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
  • PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Stryx Men, Inc.
Labeler Code: 82281
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: 10-10-2021 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.

Stryx Daily Moisturizer Spf-30 Product Label Images

Stryx Daily Moisturizer 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

Octisalate 5.00%Phenylbenzimidazole Sulfonic Acid 4.00%

Purpose

Sunscreen

Uses:

- Helps prevent sunburn- Higher SPF gives more sunburn protection- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only not intended for ingestion

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

I rash or irritation develops and lasts

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- Children under 6 months of age: ask a doctor - Reapply: 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 the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses

Other Information:

- Protect the product in this container from excessive heat and direct sun

Inactive Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bisabalol, Butyl Methoxydibenzoylmethane, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Hydrolyzed Oat Protein, Malus Domestica (Apple) Fruit Cell Culture Extract, Olea Europaea (Olive) Oil, Palmitoyl Tripeptide-5, Pentylene GLycol, Phenoxyethanol, Phenylethyl Resorcinol, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum

* Please review the disclaimer below.