NDC 14222-2440 Soothe Daily Mineral Sunscreen

Titanium Dioxide, Zinc Oxide

NDC Product Code 14222-2440

NDC 14222-2440-1

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

NDC Product Information

Soothe Daily Mineral Sunscreen with NDC 14222-2440 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Soothe Daily Mineral Sunscreen is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rodan & Fields

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Soothe Daily Mineral Sunscreen 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.

  • TITANIUM DIOXIDE .036 g/mL
  • ZINC OXIDE .0234 g/mL

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.

  • 3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552)
  • AMMONIA (UNII: 5138Q19F1X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISODODECANE (UNII: A8289P68Y2)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • NYLON-12 (UNII: 446U8J075B)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENETHYL BENZOATE (UNII: 0C143929GK)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • ROSMARINIC ACID (UNII: MQE6XG29YI)
  • RUTIN (UNII: 5G06TVY3R7)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • WATER (UNII: 059QF0KO0R)

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: Rodan & Fields
Labeler Code: 14222
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-09-2021 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.

Soothe Daily Mineral Sunscreen 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

Titanium Dioxide 3.6%
Zinc Oxide 2.34%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • When 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 Doctor If

  • Rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before use.
  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating and after towel drying.
  • 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 value of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10 AM - 2 PM.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months:Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Acrylates/Dimethicone Copolymer, Aminopropyl Triethoxysilane, Ammonium Hydroxide, Aqua/Eau/Water, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Gluconate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dipropylene Glycol, Disteardimonium Hectorite, Ethylhexylglycerin, Gluconolactone, Glycerin, Isododecane, Isostearic Acid, Magnesium Sulfate, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Nylon-12, PEG-9 Polydimethylsiloxyethyl Dimethicone, Pentylene Glycol, Phenethyl Benzoate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Rosmarinic Acid, Rutin, Silica, Sodium Benzoate, Sodium Citrate, Stearic Acid, Styrene/Acrylates Copolymer, Tocopherol, Triethylhexanoin.

Questions?

1-888-995-5656

* Please review the disclaimer below.