NDC 72667-007 Rocky Mountain Spf 30

Octocrylene, Avobenzone, Homosalate

NDC Product Code 72667-007

NDC 72667-007-01

Package Description: 3785 g in 1 BOTTLE, PLASTIC

NDC 72667-007-02

Package Description: 806 g in 1 BOTTLE, PLASTIC

NDC 72667-007-03

Package Description: 180 g in 1 BOTTLE, PLASTIC

NDC 72667-007-04

Package Description: 59 g in 1 BOTTLE, PLASTIC

NDC Product Information

Rocky Mountain Spf 30 with NDC 72667-007 is a a human over the counter drug product labeled by Inspec Solutions Llc.. The generic name of Rocky Mountain Spf 30 is octocrylene, avobenzone, homosalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Inspec Solutions Llc.

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.

Rocky Mountain 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.

  • AVOBENZONE 1.8 g/g
  • OCTOCRYLENE 5 g/g
  • HOMOSALATE 7 g/g

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.

  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CARBOMER 934 (UNII: Z135WT9208)
  • TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
  • ISOPROPYLPARABEN (UNII: A6EOX47QK0)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE 500 (UNII: 5L1VVC3K8O)
  • STEARIC ACID D7 (UNII: T3B081197X)
  • SORBITOL (UNII: 506T60A25R)

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: Inspec Solutions Llc.
Labeler Code: 72667
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: 02-11-2019 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’.

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Rocky Mountain Spf 30 Product Label Images

Rocky Mountain 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

Avobenzone - 1.8%Homosalate - 7.0%Octocrylene - 5.0%

When Using This Product

When using this product:• keep out of eyes. Rinse with water to remove.• Keep away from face to avoid breathing it.

Uses

Avobenzone - 1.8% ................. SunscreenHomosalate - 7.0% .................. SunscreenOctocrylene - 5.0% ...................Sunscreen

Warnmings

Stop use and ask a doctor if rash occurs.

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGSFor external use onlyDo not use on damaged or broken skinwhen using this product keep out of eyes-rinse with water to remove

Inactive Ingredients

Aluminum Starch OctenylsuccinateBenzyl AlcoholButyloctyl SalicylateCarbomerDimethiconeDisodium EDTAMethylparabenPolyglyceryl-3 DistearatePropylparabenSorbitan IsostearateSorbitolStearic AcidTocopherolTriethanolamineVP/Eicosene CopolymerWater

Dosage & Administration

Apply liberally 15 minutews befor sun exposureReaaply:- fter 80 monutes of swimming or sweating- immediatly after towel drying- at least every 2 hours

Indications & Usage

Helps prevent sunburnHigher SPF gives more sunburn protectionIf used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

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