NDC 72788-101 Farmhouse Fresh Elevated Shade Spf 30

Zinc Oxide

NDC Product Code 72788-101

NDC Product Information

Farmhouse Fresh Elevated Shade Spf 30 with NDC 72788-101 is a a human over the counter drug product labeled by Summer Soles Llc. The generic name of Farmhouse Fresh Elevated Shade Spf 30 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Summer Soles 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.

Farmhouse Fresh Elevated Shade 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.

  • ZINC OXIDE 21 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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ALLANTOIN (UNII: 344S277G0Z)
  • QUERCETIN (UNII: 9IKM0I5T1E)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • FLAX SEED (UNII: 4110YT348C)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TRIETHOXYSILYLPROPYL STEARDIMONIUM (UNII: 2606S334CS)
  • OXACEPROL (UNII: Q0XV76B96L)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • PISUM SATIVUM WHOLE (UNII: J21YE3W98E)

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: Summer Soles Llc
Labeler Code: 72788
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 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: 04-04-2020 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: 12-31-2021 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.

Farmhouse Fresh Elevated Shade Spf 30 Product Label Images

Farmhouse Fresh Elevated Shade 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

Zinc Oxide 21.50%

Purpose

SUNSCREEN

Uses

  • Helps protect against sunburnprovides moderate protection against sunburn

Warnings

  • Do not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to removeStop use and ask doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

  • Apply generously and evenly 15 minutes before sun exposure.Children under 6 months of age: ask doctor.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 a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10a.m. - 2p.m.wear long sleeve shirts, pants, hats and sunglasses.Reapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

Inactive Ingredients

Water/Eau, Caprylic/Capric Triglyceride, Ethyl Macadamiate, Glycerin, Propanediol, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Polyglyceryl-10 Stearate, Cetearyl Olivate, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Hyaluronate, Sodium PCA, Niacinamide, Allantoin, Quercetin, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Sodium Chloride, Glyceryl Isostearate, Polyhydroxystearic, Sorbital Olivate, Linum Usitatissmum (flax) seed oil, Tocopherol, Iron Oxides, Triethoxysilylpropyl Acetyl Hydroxyprolinate, Phenoxyethanol, Caprylyl Glycol, Polymethyl Methacrylate, Tromethamine, Pisum sativum (Dwarf Gray Sugar Pea) Extract, Parfum* *Natural fragrance derived from 100% natural sources.

* Please review the disclaimer below.