ROCKY MOUNTAIN SPF 30- octocrylene, avobenzone, homosalate lotion

Rocky Mountain SPF 30 by

Drug Labeling and Warnings

Rocky Mountain SPF 30 by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone - 1.8%

Homosalate - 7.0%

Octocrylene - 5.0%

When using this product

When using this product:

keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.

Uses

Avobenzone - 1.8% ................. Sunscreen

Homosalate - 7.0% .................. Sunscreen

Octocrylene - 5.0% ...................Sunscreen

Warnmings

Stop use and ask a doctor if rash occurs.

Warnings

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

Inactive Ingredients

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

Dimethicone

Disodium EDTA

Methylparaben

Polyglyceryl-3 Distearate

Propylparaben

Sorbitan Isostearate

Sorbitol

Stearic Acid

Tocopherol

Triethanolamine

VP/Eicosene Copolymer

Water

WARNINGS

WARNINGS

For external use only

Do not use on damaged or broken skin

when using this product keep out of eyes-rinse with water to remove

DOSAGE & ADMINISTRATION

Apply liberally 15 minutews befor sun exposure

Reaaply:

- fter 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

INDICATIONS & USAGE

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROCKY MOUNTAIN SPF 30 
octocrylene, avobenzone, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CARBOMER 934 (UNII: Z135WT9208)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
WATER (UNII: 059QF0KO0R)
DIMETHICONE 500 (UNII: 5L1VVC3K8O)
STEARIC ACID D7 (UNII: T3B081197X)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-007-01	3785 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2019
2	NDC: 72667-007-02	806 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2019
3	NDC: 72667-007-03	180 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2019
4	NDC: 72667-007-04	59 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/11/2019

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-007)