CoTZ SPF 35 Sunscreen

Dosage form: lotion
Ingredients: Zinc Oxide 200mg in 1g
Labeler: Fallien Cosmeceuticals, LTD.
NDC Code: 58892-118

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CoTZ SPF 35 Sunscreen

DRUG FACTS

Active Ingredients:

Zinc Oxide 20%.

Purpose

Sunscreen

Uses
  • Helps prevent sunburn
  • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
  • Retains SPF up to 40 minutes of water immersion or perspiring

Warnings
  • For external use only
  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients
  • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor
  • Keep this and all medications out of the reach of children
  • If swallowed, get medical help or contact a Poison Control Center

Directions
  • Apply generously and uniformly to all exposed skin areas before exposure to sunlight
  • Continue to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

Other Information

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • May stain some fabrics

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,

Manufactured
exclusively for
Fallene, Ltd.

West Norriton, PA 19403
Made in USA

Principal Display Panel – 3.5oz Carton Label

NDC 58892-118-01

Dermatologist

Recommended for

Ultra Sensitive Skin

CoTZ®

20% Zinc Oxide

vanishing formula

Pure Mineral

Sun protection

Moisturizing

water resistant

uva/uvb

SPF 35

Net. Wt. 3.5 oz./ 100g

COTZ SPF 35   SUNSCREEN
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-118
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alkyl (C12-15) Benzoate 
Caprylhydroxamic Acid 
Caprylyl Glycol 
Cyclomethicone 6 
Cyclomethicone 5 
Dimethicone 
Edetate Disodium 
Glycerin 
Hydroxystearic Acid 
Polysorbate 20 
Sodium Chloride 
Tetrahexyldecyl Ascorbate 
.Alpha.-Tocopherol Acetate, D- 
Trolamine 
Triethoxycaprylylsilane 
Water 
Packaging
#Item CodePackage Description
1NDC:58892-118-011 TUBE (1 TUBE) in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2011
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIOperations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIOperations
Custom Analytics LLC144949372ANALYSIS
Establishment
NameAddressID/FEIOperations
Harmony Labs Inc105803274MANUFACTURE, PACK

Revised: 06/2011
 
Fallien Cosmeceuticals, LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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