Search by Drug Name or NDC

NDC 58892-0430-01 CoTZ Silky Foam - Tinted 30; 100 mg/g; mg/g Details

CoTZ Silky Foam - Tinted 30; 100 mg/g; mg/g

CoTZ Silky Foam - Tinted is a TOPICAL AEROSOL, FOAM 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	58892-0430
Product ID	58892-430_04d6f889-9620-4dd2-bce2-cbbb5c717784
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 Silky Foam - Tinted
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
Route	TOPICAL
Active Ingredient Strength	30; 100
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 58892-0430-01 (58892043001)

Pricing Information	N/A
NDC Package Code	58892-430-01
Billing NDC	58892043001
Package	1 CAN in 1 CARTON (58892-430-01) / 100 g in 1 CAN
Marketing Start Date	2019-05-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d63088d7-a1d7-4b56-a7d8-ad217011a8a8 Details

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

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:

Shake well before using.
Push nozzle up to release.
Apply liberally 15 minutes before sun exposure.
Reapply:
- After 40 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 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum. Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics
Store between 68° to 104°F (20° to 40° C)
DO not store at temperature above 120° F

Manufactured Exclusively For:

CoTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®

the HEALTHIER SUNSCREEN®

Silky

Foam

Tinted

SPF

30

Vanishing Zinc Oxide

MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Can Label