FDA.reportPublic FDA data

Rocky Mountain SPF 30 Lotion

Manufacturer
Inspec Solutions LLC.
Effective date
2019-02-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:38

Label at a glance#

ProductRocky Mountain SPF 30
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 1.8%

Homosalate - 7.0%

Octocrylene - 5.0%

When using this product

OTC - WHEN USING SECTION

When using this product:

• keep out of eyes. Rinse with water to remove.

• Keep away from face to avoid breathing it.

Uses

OTC - PURPOSE SECTION

Avobenzone - 1.8% ................. Sunscreen

Homosalate - 7.0% .................. Sunscreen

Octocrylene - 5.0% ...................Sunscreen

Warnmings

OTC - STOP USE SECTION


Stop use and ask a doctor if rash occurs.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

Dimethicone

Disodium EDTA

Methylparaben

Polyglyceryl-3 Distearate

Propylparaben

Sorbitan Isostearate

Sorbitol

Stearic Acid

Tocopherol

Triethanolamine

VP/Eicosene Copolymer

Water

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutews befor sun exposure

Reaaply:

- fter 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30 Sunscreen LotionSPF 30 Sunscreen Lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72667-007-012021-01-29C16284748780-1ba0f9c33-24d6-a910-e053-dadaa90a0b85Rocky Mountain SPF 30 Lotion
72667-007-022021-01-29C16284748780-1ba0f9c33-24d6-a910-e053-dadaa90a0b85Rocky Mountain SPF 30 Lotion
72667-007-032021-01-29C16284748780-1ba0f9c33-24d6-a910-e053-dadaa90a0b85Rocky Mountain SPF 30 Lotion
72667-007-042021-01-29C16284748780-1ba0f9c33-24d6-a910-e053-dadaa90a0b85Rocky Mountain SPF 30 Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72667-007-01Rocky Mountain SPF 303785 g in 1 BOTTLE, PLASTICLOTION37851
72667-007-02Rocky Mountain SPF 30806 g in 1 BOTTLE, PLASTICLOTION8061
72667-007-03Rocky Mountain SPF 30180 g in 1 BOTTLE, PLASTICLOTION1801
72667-007-04Rocky Mountain SPF 3059 g in 1 BOTTLE, PLASTICLOTION591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72667-007ROCKY MOUNTAIN SPF 30 (OCTOCRYLENE, AVOBENZONE, HOMOSALATE) LOTION [INSPEC SOLUTIONS LLC.]1Legacy NDC, 4 package rows20190227_81a53bff-c4e9-423f-e053-2991aa0a5d79.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-00772667-007-01, 72667-007-02, 72667-007-03, 72667-007-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN ISOSTEARATE01S2G2C1E4IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
AVOBENZONEG63QQF2NOXACTIB
CARBOMER 934Z135WT9208IACT
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATEN2TK31JIAHIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)-3IIJ9C722IIACT
TOCOPHEROLR0ZB2556P8IACT
METHYLPARABENA2I8C7HI9TIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
ISOPROPYLPARABENA6EOX47QK0IACT
OCTOCRYLENE5A68WGF6WMACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
DIMETHICONE 5005L1VVC3K8OIACT
STEARIC ACID D7T3B081197XIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
81a53bff-c4ea-423f-e053-2991aa0a5d7981a53bff-c4e9-423f-e053-2991aa0a5d792019-02-11WarningsExact identifier
spl id: 81a53bff-c4ea-423f-e053-2991aa0a5d79
spl set id: 81a53bff-c4e9-423f-e053-2991aa0a5d79

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.