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NDC 58892-0349-01 CoTZ Mineral Suns Stick - Tinted SPF 45 40; 55 mg/g; mg/g Details

CoTZ Mineral Suns Stick - Tinted SPF 45 40; 55 mg/g; mg/g

CoTZ Mineral Suns Stick - Tinted SPF 45 is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Fallien Cosmeceuticals, LTD. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	58892-0349
Product ID	58892-349_6625710b-df56-4379-8f4f-8d1da05cf30d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CoTZ Mineral Suns Stick - Tinted SPF 45
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	40; 55
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Fallien Cosmeceuticals, LTD
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58892-0349-01 (58892034901)

Pricing Information	N/A
NDC Package Code	58892-349-01
Billing NDC	58892034901
Package	1 CYLINDER in 1 CARTON (58892-349-01) / 30 g in 1 CYLINDER
Marketing Start Date	2022-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 44a6ff9b-8067-4f32-acb2-4ede54c79e6e Details

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 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

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 10am-2pm
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, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics

Manufactured Exclusively For:

CoTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®

the HEALTHIER SUNSCREEN®

Mineral Sun Stick

Tinted

SPF

45

SHEER

MINERAL SUNSCREEN

FACE & BODY

SPF 45 Broad Spectrum

Water Resistant (80 Minutes)

Net Wt. 1 oz./30 g.

INGREDIENTS AND APPEARANCE

COTZ MINERAL SUNS STICK - TINTED SPF 45

titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58892-349
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)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
HEXYLDECANOL (UNII: 151Z7P1317)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
FERRIC OXIDE RED (UNII: 1K09F3G675)
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:58892-349-01	1 in 1 CARTON	04/01/2022
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	04/01/2022

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-349)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-349) , PACK(58892-349) , LABEL(58892-349)

Revised: 8/2022

Document Id: 6625710b-df56-4379-8f4f-8d1da05cf30d

Set id: 44a6ff9b-8067-4f32-acb2-4ede54c79e6e

Version: 1

Effective Time: 20220815