COTZ PEDIATRIC SPF 40  SUNSCREEN - zinc oxide lotion 
Fallien Cosmeceuticals, LTD.

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.



Active Ingredients:

Zinc Oxide 20 %




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.


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.


Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Getyl PEG/PPG 10/1 Dimethicone, Cyelohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dlmethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydraxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

Principal Display Panel – SPF 40 100g Carton Label




The Healthier SunscreenTM Gentle Mineral ComplexTM #1 Rated UV Protection*
Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Fragrances

SPF 40

Easy to Apply
Water Resistant
(40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – SPF 40 100g Carton Label
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-518
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) (UNII: 035JKJ76MT)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone 100 (UNII: RO266O364U)  
Dimethicone/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK)  
Edetate Disodium (UNII: 7FLD91C86K)  
Methicone (20 cst) (UNII: 6777U11MKT)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0)  
PEG-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sodium Chloride (UNII: 451W47IQ8X)  
Stearyl Dimethicone (400 MPA.S AT 50C) (UNII: R327X197HY)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Trolamine (UNII: 9O3K93S3TK)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Water (UNII: 059QF0KO0R)  
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58892-518-01 1 in 1 CARTON
1 100 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/07/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Name Address ID/FEI Business Operations
Custom Analytics LLC 144949372 ANALYSIS(58892-518)
Name Address ID/FEI Business Operations
Process Technologies & Packaging 809172885 MANUFACTURE(58892-518)

Revised: 12/2012
Document Id: 6d2bf152-c7e9-4e52-9615-dfe0120cab79
Set id: e6b965a9-8dab-485f-b8f1-8f7dcb453e6e
Version: 1
Effective Time: 20121219
Fallien Cosmeceuticals, LTD.