FLORIDA SALT SCRUBS FLORIDA GROWN BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octisalate, and octocrylene spray

Florida Salt Scrubs by

Drug Labeling and Warnings

Florida Salt Scrubs 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 2%

Octisalate 5%

Octocrylene 1.85%

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 in the presence of a flame or spark. Keep away from sources of ignition- No smoking. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF.

Do not use on damaged or broken skin

When using this product keep away from face to avoid breathing it. Keep out of eyes. Rinse with water to remove.

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

• hold container 4 to 6 inches from the skin to apply.
• spray liberally and spread evenly by hand 15 minutes before sun exposure.
• do not spray directly unto face. Use in a well ventilated area.
• reapply
• after 80 minutes of swimming or sweating
• inmediately 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 of 15 or higher and other sun protection measures, including:
• limit time in the sun, specially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats & sunglasses.
• children under 6 months: Ask a doctor.

Inactive ingredients

Cocos Nucifera (Coconut) Oil, Diethylhexyl 2, 6-Naphthalate, Fragrance, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• protect this product from excessive heat and direct sun
• avoid spraying on fabrics - could cause discoloration

Question or comments?

1 (800) 931-9524

Florida Grown Broad Spectrum SPF 15 Sunscreen

INGREDIENTS AND APPEARANCE

FLORIDA SALT SCRUBS  FLORIDA GROWN BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.34 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40.85 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15.11 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIBUTYL MALEATE (UNII: 4X371TMK9K)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0122-4	177 mL in 1 CAN; Type 0: Not a Combination Product	07/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/31/2017

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0122) , analysis(13630-0122)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0122) , label(13630-0122)