ROCKY MOUNTAIN SPF 50- avobenzone, humosalate, octisalate, octocrylene spray

HashtagSUN SPF 50 SunScreen Dabber by

Drug Labeling and Warnings

HashtagSUN SPF 50 SunScreen Dabber by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Avobenzone 3.0%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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.

PURPOSE

Avobenzone 3.0% ……………………………………………………………………………… Sunscreen

Homosalate 15.0% ……………………………………………………………………………. Sunscreen

Octisalate 5.0% …………………………………………………………………………………. Sunscreen

Octocrylene 10.0% ……………………………………………………………………………. Sunscreen

STOP USE

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 Salicylate

Caprylyl Methicone Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Fragrance

Glyceryl Stearate Hydrated Silica

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/Acrylates Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolymer

Water

Xanthan Gum

WHEN USING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROCKY MOUNTAIN SPF 50 
avobenzone, humosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-001
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-001-01	177 mL in 1 CAN; Type 0: Not a Combination Product	11/12/2018
2	NDC: 72667-001-02	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2018
3	NDC: 72667-001-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2018
4	NDC: 72667-001-04	177 mL in 1 CAN; 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 (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(72667-001)