DRUG FACTS

Active Ingredients

Titanium Dioxide 7% and Zinc Oxide 10%

Purpose

Sunscreen

Uses:

Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.

Warning:

For external use only.

Do not use

on damaged or broken skin.

When using this product

avoid contact with eyes, contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor

If irritation or rash develops or persists.

Keep out of reach of children.

If swallowed, seek immediate medical attention of contact a Poison Control Center right away.

Directions:

Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply at least every 2 hours.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses. Sun protection measures:

: Consult a physician. For use on children under 6

Other information:

Protect this product from excessive heat or direct sun.

INACTIVE INGREDIENTS:

ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.

Package Labeling:

Label2 Label

SPIT AND POLISH SUN SMART SUNSCREEN
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80325-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	70 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
WHITE WAX (UNII: 7G1J5DA97F)
CARROT (UNII: L56Z1JK48B)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80325-001-01	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/01/2020

Labeler - Naturally Uncommon, LLC (044473410)

Spit & Polish Sun Smart Sunscreen Lotion SPF 50