SPF 50 Sunscreen

Manufacturer
Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:42

Label at a glance#

ProductSPF 50 Sunscreen Rocky Mountain
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including: limit time in the sun, especial...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only. Flammable: do not use while smoking or near heat or flame.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

Apply liberally 15 minutes before sun exposure. Reapply:

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

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do no apply in windy conditions. Use in a well-ventilated area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Glycerin, Stearoxytrimethysilane, Tocopherol.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Label2Label2

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Label 4Label 4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-543-06SPF 50 SunscreenRocky Mountain177 mL in 1 CANSPRAY1773
72839-543-16SPF 50 SunscreenRocky Mountain473 mL in 1 BOTTLE, PUMPSPRAY4733
72839-543-32SPF 50 SunscreenRocky Mountain946 mL in 1 BOTTLE, PUMPSPRAY9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-543SPF 50 SUNSCREEN ROCKY MOUNTAIN (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%) SPRAY [DERMA CARE RESEARCH LABS, LLC]3Current NDC, Legacy NDC, 3 package rows20241222_a1c9066c-4801-5aee-e053-2995a90a75d2.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-54372839-543-06, 72839-543-16, 72839-543-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
SPF 50 Sunscreen Rocky MountainAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCa1c9066c-4801-5aee-e053-2995a90a75d22024-12-19WarningsExact identifier
ndc (package): 72839-543-06
ndc (package): 72839-543-32
ndc (package): 72839-543-16
ndc (product): 72839-543
ndc11 (package): 72839054316
ndc11 (package): 72839054306
ndc11 (package): 72839054332
spl id: 29a617df-d38b-dcbc-e063-6394a90a43f2
spl set id: a1c9066c-4801-5aee-e053-2995a90a75d2

Reported adverse events (FAERS/openFDA)#

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