COTZ KIDS MINERAL SUN STICK- titanium dioxide, zinc oxide stick

CoTZ Kids Mineral Sun Stick by

Drug Labeling and Warnings

CoTZ Kids Mineral Sun Stick by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 4% 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 - At least every 2 hours - Children under 6 months: Ask a doctor.

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, Ethylhexyl 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.

Warning:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COTZ KIDS MINERAL SUN STICK 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HEXYLDECANOL (UNII: 151Z7P1317)
PEG-8 (UNII: B697894SGQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CERESIN (UNII: Q1LS2UJO3A)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
ALUMINA (UNII: LMI26O6933)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID (UNII: 2968PHW8QP)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-362-30	1 in 1 CARTON	03/03/2025
1		30 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/03/2025

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-362)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-362)