OTC Medication Information: SPF 50 Sunscreen Rocky Mountain

SPF 50 SUNSCREEN ROCKY MOUNTAIN- avobenzone, homosalate and octocrylene lotion
Derma Care Research Labs, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Avobenzone 3%, Homosalate 10%, Octocrylene 6%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

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.

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

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

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

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

Label 1
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Label 2
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Label 3
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Label 4
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Label 5
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Label 6
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SPF 50 SUNSCREEN ROCKY MOUNTAIN
avobenzone 3%, homosalate 10%, octocrylene 6% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-159
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
EICOSYL POVIDONE
STEARIC ACID
POLYGLYCERYL-3 DISTEARATE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
ALUMINUM STARCH OCTENYLSUCCINATE
EDETATE DISODIUM
BUTYLOCTYL SALICYLATE
DIMETHICONE 20
CARBOMER 940
SORBITAN ISOSTEARATE
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72839-159-02 59 mL in 1 BOTTLE, PLASTIC None
2 NDC:72839-159-06 177 mL in 1 BOTTLE, PLASTIC None
3 NDC:72839-159-32 946 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/27/2020
Labeler — Derma Care Research Labs, LLC (116817470)
Registrant — Derma Care Research Labs, LLC (116817470)

Revised: 03/2020 Derma Care Research Labs, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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