DRUG FACTS

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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. Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

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

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
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 value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 am-2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, EthylhexI Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

Protect this product from excessive heat and direct sun

Principal Display Panel – 30 g Carton Label

TiZO®

MINERAL STICK

Non-Tinted

MINERAL SUNSCREEN
FOR BODY & FACE

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 1 Oz./30 g

Principal Display Panel – 30 g Carton Label

TIZO MINERAL STICK NON-TINTED SPF 45
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58892-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	55 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
CERESIN (UNII: Q1LS2UJO3A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINGER OIL (UNII: SAS9Z1SVUK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58892-123-30	1 in 1 CYLINDER	07/01/2022
1		30 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/01/2022

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-123)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-123) , PACK(58892-123)