NDC 73072-002 Rain Or Shine

Octinoxate Homosalate Octisalate Titanium Dioxide

NDC Product Code 73072-002

NDC Product Information

Rain Or Shine with NDC 73072-002 is a a human over the counter drug product labeled by Jaxon Lane, Inc.. The generic name of Rain Or Shine is octinoxate homosalate octisalate titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jaxon Lane, Inc.

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.

Rain Or Shine 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.

  • OCTINOXATE 7 g/100mL
  • HOMOSALATE 3 g/100mL
  • OCTISALATE 3 g/100mL
  • TITANIUM DIOXIDE 1.5 g/100mL

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)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
  • LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • ALLANTOIN (UNII: 344S277G0Z)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)

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: Jaxon Lane, Inc.
Labeler Code: 73072
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: 07-25-2019 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.

Rain Or Shine 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

Octinoxate, Homosalate, Octisalate, titanium dioxide

Otc - Purpose

Purpose: Sunscreen

Inactive Ingredients

Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

Uses:

Helps prevent sunburn. 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. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours and after swimming. Children under 6 months: Ask a doctor.Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants.

Other Information:

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.

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