MKRS BROAD SPECTRUM SPF50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

MKRS by

Drug Labeling and Warnings

MKRS by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3 %, Homosalate 10%, Octisalate 5 %,  Octocrylene 2.75 %, and Oxybenzone 4 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.
• keep away from face to avoid breathing it
• Contents under pressure - do not punture or incinerate. Do not store at temperature above 120°F

Stop use and ask a doctor if rash occurs

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

Flammable: Do not use near heat, flame or while smoking.

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure.
• 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 not apply in windy conditions
• Use in a well-ventilated area
• reapply:
• After 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

Fragrance, SD Alcohol 40-B (Alcohol Denat.), Menthyl Ethylamido Oxalate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• protect this product from exessive heat and direct sun
• may stain some fabrics

Questions or comments? Prime Enterprises, Inc.

16363 NW 49 Avenue. Miami. FL 33014

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

MKRS

attorneys at law

Serving Florida since 1958

CONTINUOUS SPRAY

SUNSCREEN

COOLING

50

Broad Spectrum SPF 50

Water Resistant (80 Minutes)

NON-GREASY FORMULA

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

MKRS  BROAD SPECTRUM SPF50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	96 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	48 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	38.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYL MALEURATE (UNII: 6FUA0H660I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0091-4	177 mL in 1 CAN; Type 0: Not a Combination Product	08/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2015

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0091) , analysis(13630-0091)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0091) , pack(13630-0091)