SPF 50 SUNSCREEN ROCKY MOUNTAIN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% spray

SPF 50 Sunscreen by

Drug Labeling and Warnings

SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

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.

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.

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

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

Label

INGREDIENTS AND APPEARANCE

SPF 50 SUNSCREEN  ROCKY MOUNTAIN
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-543
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-543-06	177 mL in 1 CAN; Type 0: Not a Combination Product	03/27/2020
2	NDC: 72839-543-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/27/2020
3	NDC: 72839-543-32	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/27/2020

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)