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NDC 58892-0618-01 CoTZ Baby 200 mg/g Details

CoTZ Baby 200 mg/g

CoTZ Baby is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Fallien Cosmeceuticals, LTD. The primary component is ZINC OXIDE.

Product Information

NDC	58892-0618
Product ID	58892-618_1017da7d-eee5-4605-b4fe-5353c7781be9
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 Baby
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/g
Substance Name	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 58892-0618-01 (58892061801)

Pricing Information	N/A
NDC Package Code	58892-618-01
Billing NDC	58892061801
Package	1 TUBE in 1 CARTON (58892-618-01) / 100 g in 1 TUBE
Marketing Start Date	2019-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 17cc12c7-5af8-413f-b205-31ac150583e2 Details

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

Zinc Oxide 20%

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 40 minutes of swimming or sweating

-

Immediately after towel drying

-

At least every two 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:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

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 – CoTZ Baby Tube Label

CoTZ®

the HEALTHIER

SUNSCREEN®

Baby

Non-Tinted

SPF

40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – CoTZ Baby Carton Label