MIAMI BEACH SEA SUNSCREEN 30 BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Miami Beach by

Drug Labeling and Warnings

Miami Beach 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%

Oxybenzone 4%

Purpose

Sunscreen

Uses

helps prevent 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

For external use only

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

Do not use on damaged or broken skin

When using this product Keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

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.

Directions

spray liberally and spread evenly by hand 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating

inmediately after towel drying at least every 2 hours

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

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 of 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

Acrylates/Octylacrylamide Copolymer, Fragrance, Propylene Glycol, Water, Pseudopterogorgia Elisabethae Plant Extract, SD Alcohol (Alcohol Denat.).

Other information

protect this product from excessive heat and direct sun.

may stain fabrics.

Question or comments?

Call 305.592.8565

Miami Beach Sport Sunscreen Spray 30

INGREDIENTS AND APPEARANCE

MIAMI BEACH  SEA SUNSCREEN 30 BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	24.75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0126-4	177 mL in 1 CAN; Type 0: Not a Combination Product	03/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/15/2018

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0126) , analysis(13630-0126)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	label(13630-0126) , pack(13630-0126)