ROCKY MOUNTAIN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Rocky Mountain SPF 50 by

Drug Labeling and Warnings

Rocky Mountain SPF 50 by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

USE IN SPECIFIC POPULATIONS

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

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

WHEN USING

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

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

INACTIVE INGREDIENT

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROCKY MOUNTAIN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-002-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2018
2	NDC: 72667-002-02	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/12/2018
3	NDC: 72667-002-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	11/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/12/2018

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-002)