Rocky Mountain SPF 50 Lotion

Manufacturer
Inspec Solutions LLC.
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:44:16

Label at a glance#

ProductRocky Mountain SPF 50
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

USE IN SPECIFIC POPULATIONS SECTION

Uses

• Helps prevent sunburn, higher SPF gives more sunburn protection

• retains SPF after XX minutes of activity in the water or sweating

• provides moderate protection against 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 SECTION

WARNINGS

For external use only.

Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

When using this product:

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

• Keep away from face to avoid breathing it.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

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

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.

• Do not puncture or incinerate, Contents under pressure

• Do not store at temperature above 120⁰F

Stop use and ask a doctor if rash occurs.

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 INGREDIENT SECTION

Behenyl Alcohol

BHT

Butyloctyl Salocylate

Caprylyl Methicone

Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Glyceryl Stearate

Hydrated Silicia

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/ Acrylate Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolyer

Water

Xanthan Gum

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

• Apply liberally 15 minutes before sun exposure.

• Reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

٠Hold container 4 to 6 inches from the skin to apply.
٠Do not spray directly into face. Spray on hands then apply to face.
٠Do not apply in windy conditions.
٠Use in a well-ventilated area.
٠For sunscreen use
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROCKY MOUNTAIN SUNSCREEN SPF 50 Lotion GallonROCKY MOUNTAIN SUNSCREEN SPF 50 Lotion Gallon

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-00272667-002-01, 72667-002-02, 72667-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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
ce40cf8d-3895-b526-e053-2995a90ac5597be336b5-3bb2-4006-e053-2991aa0aa71e2021-10-13WarningsExact identifier
spl set id: 7be336b5-3bb2-4006-e053-2991aa0aa71e

Reported adverse events (FAERS/openFDA)#

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