FLORIDA GLOW SPF 30- zinc oxide lotion

Florida Glow SPF 30 by

Drug Labeling and Warnings

Florida Glow SPF 30 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                    

Zinc Oxide   14.6%

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 occurs.

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, Coco-Caprylate/Caprate, Isoamyl laurate, Glycerine, Polyglyceryl -6 Stearate, Jojoba Oil, Propanadiol, Shea Butter, Xanthum Gum, Phenoxyethanol, Green Tea Leaf Extract, Cetyl Alcohol, Silica, Polyhydroxystearic Acid, Pongomia Pinnata Seed Extract, Sphingomonas Ferment Extract, Aloe Barbadensis Leaf Extract, Lecithin, Sclerotium Gum, Pullulan, Ethylhexylglycerin

Other Information

• Protect this product from heat and direct sun.
• May stain or damage some fabrics or surfaces. 

SPL UNCLASSIFIED SECTION

Questions or Comments?
Call 1 (800) 931-9254

Product label

INGREDIENTS AND APPEARANCE

FLORIDA GLOW SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83862-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
JOJOBA OIL (UNII: 724GKU717M)
PROPANEDIOL (UNII: 5965N8W85T)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETYL ALCOHOL (UNII: 936JST6JCN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
SPHINGOFUNGIN C (UNII: S0392RT2G8)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PULLULAN (UNII: 8ZQ0AYU1TT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83862-005-01	100 mL in 1 TUBE; 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(83862-005) , label(83862-005) , pack(83862-005)