TIZO ULTRA NON TINTED MINERAL SUNSCREEN- zinc oxide 20% spray

Drug Labeling and Warnings

Drug Details [pdf]

Zinc Oxide 20% ........................................................ Sunscreen

PURPOSE

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

Do not useon damaged or broken skin.

When using this product■ keep out of eyes. Rinse eyes with water
to remove.
Stop use and ask a doctor ifrash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Polson Control Center right away.

Directions

 ■ apply liberally 15 minutes before sun exposure.
Reapply: ■ after 40 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 risk, regularly use a
sunscreen with broad spectrum SPF of 15 or higher and other sun
protection measures lncludlng: ■ limit time In the sun, especlally
from 10am to 2pm ■ wear long-sleeved shirts, pants, hats, and
sunglasses ■ children under 6 months: ask a doctor ■ do not spray
directly Into face. Spray on hands then apply to face ■ use In
well-ventilated area.

Other information

protect this product from excessive
heat and direct sun ■ may stain fabrics.

Inactive Ingredients

Cyclopentasiloxane
Dimethicone Crosspolymer
Cyclopentasiloxane
Cyclohexasiloxane
Cyclopentasiloxane
Dimethiconol
Stearyl Dimethicone
Octadecene
Dimethicone
Polyglyceryl-4 Isostearate
Cetyl PEG/PPG-10/1 Dimethicone
PEG-30 Dipolyhydroxystearate
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
C12-15 Alkyl Benzoate
Microcrystalline Wax
Caprylhydroxamic Acid
Caprylyl Glycol
Glycerin

Disodium EDTA
Sodium Chloride
Polysorbate 20
Triethanolamine
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO ULTRA NON TINTED MINERAL SUNSCREEN 
zinc oxide 20% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ORYZA SATIVA (RICE) SEED OIL (UNII: ACU8G2V809)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-071-04	100 g in 1 TUBE; Type 0: Not a Combination Product	08/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	08/21/2025

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Registrant - Inspec Solutions LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(58892-071)