Florida Glow Broad Spectrum SPF 15

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]

FLORIDA SUNCARE BROAD SPECTRUM SPF 15- avobenzone,octisalate, octocrylene spray 
Prime Packaging, Inc.

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Florida Glow Broad Spectrum SPF 15

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 2%

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 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 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 15

FLORIDA SUNCARE  BROAD SPECTRUM SPF 15
avobenzone,octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	16.3 mg  in 1 mL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0235-4	191 mL in 1 CAN; Type 0: Not a Combination Product	08/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/18/2017

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0235) , analysis(13630-0235)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	pack(13630-0235) , label(13630-0235)

Revised: 1/2024

Document Id: 0fc6bfd6-332b-eed7-e063-6394a90a2691

34390-5

Set id: d0d96639-d517-4dbb-e053-2995a90a06c5

Version: 5

Effective Time: 20240125