FLORIDA GLOW FACE SHIELD SPF 55- homosalate, octocrylene, zinc oxide lotion

Florida Glow face shield SPF 55 by

Drug Labeling and Warnings

Florida Glow face shield SPF 55 by is a Otc medication manufactured, distributed, or labeled by Southeast Holdings Corp., Southeast Holdings Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients                    

Homosalate  10%                          
Octocrylene  5%
Zinc Oxide   5.8%

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.

Stop use and ask a doctorif rash or irritation develops and lasts.

Do not useon damaged or broken skin.

When using this productKeep out of eyes.Rinse with water to remove.

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

KEEP OUT OF REACH OF CHILDREN

Directions

Apply liberally 15 minutes before sun exposure
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
at least every 2 hours.
Children under 6 months: Ask a doctor.
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 Broad Spectrum of 15 or nigher and other sun protection measures, including:
limit time in the sun, espec1ally from 10 a.m.- 2 p.m.
wear long sleeve shirts, pants, hats & sunglasses

Inactive Ingredients

Triethoxycaprylylsilane, Water, Ethylhexyl Stearate, Isopropyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone, Hydrogenated Polyisobutene , Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Methylisothiazolinone, Caprylyl Glycol, Sodium Chloride, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Silica, Polyglyceryl-3 Oleate

Other Information

protect this product from heat and direct sun.

SPL UNCLASSIFIED SECTION

Questions or Comments?
Call 1 (754) 214-9379

Product label

INGREDIENTS AND APPEARANCE

FLORIDA GLOW FACE SHIELD SPF 55 
homosalate, octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83862-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83862-004-01	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/19/2021

Labeler - Southeast Holdings Corp. (122400191)

Establishment
Name	Address	ID/FEI	Business Operations
Southeast Holdings Corp		080504027	manufacture(83862-004) , label(83862-004) , pack(83862-004)