FLORIDA SUNCARE BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

Florida Suncare by

Drug Labeling and Warnings

Florida Suncare 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 5%

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 120°F.

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 into face. Spray on hand then apply to face.
• do not apply in windy conditions. Use in 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 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 & sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Cocos Nucifera (coconut) Oil, Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

Other information

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

Questions or comments?

Call 1 (800) 931-9254

Florida Glow Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

FLORIDA SUNCARE  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	83.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.65 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)

Product Characteristics
Color	yellow (very light Yellow to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0234-4	187 mL in 1 CAN; Type 0: Not a Combination Product	08/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/23/2017

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0234) , analysis(13630-0234)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0234) , pack(13630-0234)