FDA.reportPublic FDA data

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 ingredientAVOBENZONE, 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 10%, Octocrylene 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polyglceryl-3 Distearate, Sorbitan Isostearate, Sorbitol, Stearic Acid, Triethanolamine, VP/Eicosene Copolymer, Water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

Label 3Label 3

Label 4Label 4Label 5Label 5Label 6Label 6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-159-02SPF 50 SunscreenRocky Mountain59 mL in 1 BOTTLE, PLASTICLOTION593
72839-159-06SPF 50 SunscreenRocky Mountain177 mL in 1 BOTTLE, PLASTICLOTION1773
72839-159-32SPF 50 SunscreenRocky Mountain946 mL in 1 BOTTLE, PUMPLOTION9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-159SPF 50 SUNSCREEN ROCKY MOUNTAIN (AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%) LOTION [DERMA CARE RESEARCH LABS, LLC]3Current NDC, Legacy NDC, 3 package rows20241222_a216d48f-4ed4-6008-e053-2a95a90a8c9a.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-15972839-159-02, 72839-159-06, 72839-159-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
STEARIC ACID4ELV7Z65APIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
EDETATE DISODIUM7FLD91C86KIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE 20H8YMB5QY0DIACT
CARBOMER 9404Q93RCW27EIACT

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 10%, OCTOCRYLENE 6%Derma Care Research Labs, LLCa216d48f-4ed4-6008-e053-2a95a90a8c9a2024-12-19WarningsExact identifier
ndc (package): 72839-159-02
ndc (package): 72839-159-32
ndc (package): 72839-159-06
ndc (product): 72839-159
ndc11 (package): 72839015906
ndc11 (package): 72839015932
ndc11 (package): 72839015902
spl id: 29a578a8-e2e2-a79d-e063-6294a90aa2a6
spl set id: a216d48f-4ed4-6008-e053-2a95a90a8c9a

Reported adverse events (FAERS/openFDA)#

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